Randomized Controlled Trial Comparing Flexible and Continuous Positive Airway Pressure Delivery: Effects on Compliance,Objective and Subjective Sleepiness and Vigilance

Study Objectives:

Positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) can be limited by suboptimal compliance. C-Flex technology (Philips Respironics, PA, USA) reduces pressure during expiration, aiming to improve comfort and therefore compliance. This may be of particular relevance to patients requiring high pressures. Many studies thus far have suffered from design limitations and small sample sizes. This study aimed to compare compliance with C-Flex and CPAP, as well as analyzing objective and subjective sleepiness and vigilance.

Design:

Three-month, double-blinded, parallel-arm randomized controlled trial.

Setting:

A university-based sleep laboratory.

Patients:

76 consecutive patients with severe OSA (mean ± SD AHI 60.2 ± 32.9 events/hour, ESS 13.6 ± 4.5/24, BMI 35.6 ± 7.8 kg/m²), without significant cardiac, respiratory, psychiatric, or sleep comorbidities.

Interventions:

Patients were randomized to C-Flex (dip level 2) or CPAP.

Measurements and Results:

Patients underwent titration with C-Flex/CPAP (mean pressure 11.6 cm H₂O). Modified maintenance of wakefulness tests (mod-MWT), psychomotor vigilance tasks (PVT) and questionnaires were administered at baseline and after one and 3 months. Median compliance was 5.51 and 5.89 h/ night in the C-Flex and CPAP groups respectively (P = 0.82). There were no significant differences between groups in terms of PVT reaction time, subjective sleepiness, sleep quality, health-related quality of life, or treatment comfort. There was no significant difference between the groups regarding the change in mod-MWT sleep latency values.

Conclusions:

In patients with severe OSA both CPAP and C-Flex resulted in substantial improvements in sleepiness, vigilance, and quality of life. The use of C-Flex did not result in greater compliance, and neither treatment appeared superior.

Citation:

Bakker J; Campbell A; Neill A. Randomized controlled trial comparing flexible and continuous positive airway pressure delivery: effects on compliance, objective and subjective sleepiness and vigilance. SLEEP 2010;33(4):523-529.     

Irregular Respiration as a Marker of Wakefulness During Titration of CPAP

Study Objectives:

Regularity of respiration is characteristic of stable sleep without sleep disordered breathing. Appearance of respiratory irregularity may indicate onset of wakefulness. The present study examines whether one can detect transitions from sleep to wakefulness using only the CPAP flow signal and automate this recognition.

Design:

Prospective study with blinded analysis

Setting:

Sleep disorder center, academic institution.

Participants:

74 subjects with obstructive sleep apnea/hypopnea syndrome (OSAHS)

Interventions:

n/a

Measurements and Results:

74 CPAP titration polysomnograms in patients with OSAHS were examined. First we visually identified characteristic patterns of ventilatory irregularity on the airflow signal and tested their relation to conventional detection of EEG defined wake or arousal. To automate recognition of sleep-wake transitions we then developed an artificial neural network (ANN) whose inputs were parameters derived exclusively from the airflow signal. This ANN was trained to identify the visually detected ventilatory irregularities. Finally, we prospectively determined the accuracy of the ANN detection of wake or arousal against EEG sleep/wake transitions. A visually identified irregular respiratory pattern (IrREG) was highly predictive of appearance of EEG wakefulness (Positive Predictive Value [PPV] = 0.89 to 0.98 across subjects). Furthermore, we were able to automate identification of this irregularity with an ANN which was highly predictive for wakefulness by EEG (PPV 0.66 to 0.86).

Conclusions:

Despite not detecting all wakefulness, the high positive predictive value suggests that analysis of the respiration signal alone may be a useful indicator of CNS state with potential utility in the control of CPAP in OSAHS. The present study demonstrates the feasibility of automating the detection of IrREG.

Citation:

Ayappa I; Norman RG; Whiting D; Tsai AHW; Anderson F; Donnely E; Silberstein DJ; Rapoport DM. Irregular respiration as a marker of wakefulness during titration of CPAP. SLEEP 2009;32(1):99-104.     

Evaluation of Sham-CPAP as a Placebo in CPAP Intervention Studies

Study Objectives:

To evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention.

Design and Setting:

Analysis of polysomnograms performed in fixed order without sham-CPAP and on the first night of the sham-CPAP intervention in participants in the CPAP Apnea Trial North American Program (CATNAP), a randomized, placebo controlled trial evaluating the effects of CPAP treatment on daytime function in adults with newly diagnosed mild to moderate obstructive sleep apnea (apnea hypopnea index (AHI) 5 - 30).

Participants:

The first 104 CATNAP participants randomized to the sham-CPAP intervention arm.

Measurements and Results:

Compared to the polysomnographic measures without sham-CPAP, the study on the first night with sham-CPAP had statistically significant differences that suggested a decrease in sleep quality: decreased sleep efficiency, increased arousal index, increased time in stage 1 NREM sleep, and prolonged latency to REM sleep. However, all of these differences had a relatively small effect size. Compared to the polysomnogram without sham-CPAP, the number of hypopneas on the sham-CPAP polysomnogram was significantly increased and the number of apneas significantly decreased. Relatively minor differences in AHI with and without sham-CPAP were present and were dependent on the criteria used to score hypopneas.

Conclusion:

Comparison of polysomnograms with and without sham-CPAP revealed differences that, although statistically significant, were small in magnitude and had relatively low effect sizes suggesting minimal clinical significance. The results support the use of sham-CPAP as a placebo intervention in trials evaluating the effects of CPAP treatment in patients with obstructive sleep apnea.

Clinical Trial Information:

This paper was a secondary analysis of clinical trial data. CATNAP: CPAP Apnea Trial North American Program, the trial from which the data were obtained, is registered with clinicaltrial.gov. Registration #{"type":"clinical-trial","attrs":{"text":"NCT00089752","term_id":"NCT00089752"}}NCT00089752.

Citation:

Rodway GW; Weaver TE; Mancini C; Cater J; Maislin G; Staley B; Ferguson KA; George CFP; Schulman DA; Greenberg H; Rapoport DM; Walsleben JA; Lee-Choing T; Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. SLEEP 2010;33(2):260-266.     

Neighborhood of Residence is Associated with Daily Adherence to CPAP Therapy

Study Objectives:

Adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea is poor. Risk factors for nonadherence are not well understood but may reflect individual or neighborhood socioeconomic factors. We sought to determine the association of socioeconomic status and initial CPAP adherence.

Design:

Retrospective cohort study, 2005 to 2006.

Setting:

Philadelphia VA Medical Center.

Participants:

Of 330 consecutive veterans who met study criteria for initiation of CPAP therapy for newly diagnosed sleep apnea, 266 had complete data for study inclusion.

Interventions:

N/A.

Measurements:

Through a multivariable logistic regression model, using an outcome of objectively measured CPAP use ≥ 4 h daily during the first week of treatment, we tested whether patients from higher socioeconomic neighborhoods had higher CPAP adherence. We measured neighborhood socioeconomic status with an index derived from the 2000 U.S. Census at the block group-level composed of median household income, male and female employment, adult high school completion, married households, and minority composition.

Results:

CPAP adherence ≥ 4 h occurred on 48.9% of 1,805 patient-days observed for the 266 subjects. After adjustment for individual sociodemographic characteristics and medical comorbidity, the probability of daily CPAP use ≥ 4 h ranged from 34.1% (95% CI, 26.4–42.7) for subjects from a low socioeconomic neighborhood (5th percentile) to 62.3% (95% CI, 53.8–70.1) for subjects from a high (95th percentile) neighborhood.

Conclusions:

In a retrospective cohort of veterans, initial CPAP adherence was closely associated with higher neighborhood socioeconomic factors. Future investigation should target specific impediments to adherence in the home and neighborhood environment.

Citation:

Platt AB; Field SH; Asch DA; Chen Z; Gupta R; Roche DF; Gurubhagavatula I; Christie JD; Kuna ST. Neighborhood of residence is associated with daily adherence to CPAP therapy. SLEEP 2009;32(6):799-806.     

Effects of Continuous Positive Airway Pressure on Quality of Life in Patients With Moderate to Severe Obstructive Sleep Apnea: Data From a Randomized Controlled Trial

Study Objectives:

Previous studies have shown that CPAP has a substantial impact on daytime symptoms and quality of life (QOL). It remains unclear which outcome measures best identify real CPAP effects and carry independent information.

Methods:

One hundred-two men with moderate-severe obstructive sleep apnea were randomized to either “real” or “sham” CPAP for one month. Outcome measures were subjective sleepiness (Epworth Sleepiness Scale [ESS]) and QOL measures including SF-36/SF-12 and Calgary Sleep Apnea Quality of Life Index (SAQLI). The bed partner''s QOL and rating of patient''s response to CPAP were assessed with the Dublin questionnaire. All data were standardized using effect sizes and expressed as real minus sham to remove the nonspecific effects of placebo.

Results:

Real CPAP was superior to sham CPAP in almost all outcome measures. ESS, patient''s component from Dublin, and social interactions from SAQLI showed the largest differences in effect sizes between real and sham (1.33, 0.98, and 0.92 respectively). ESS carried the highest predictive power of real CPAP response (P < 0.0001, r² = 0.21). Question number 5 from Dublin (partner assessed patient''s sleep quality) and question 6 from ESS (dozing while talking) were the best single item predictors of real CPAP response.

Conclusions:

Real CPAP reduces subjective sleepiness and improves QOL of both patients and bed partners. ESS is the best score; question number 5 from Dublin and question number 6 from ESS are the best single item predictors of real CPAP response. This information should allow the selection of appropriate questions in clinical practice and research protocols.

Citation:

Siccoli MM; Pepperell JCT; Kohler M; Craig SE; Davies RJO; Stradling JR. Effects of continuous positive airway pressure on quality of life in patients with moderate to severe obstructive sleep apnea: data from a randomized controlled trial. SLEEP 2008;31(11):1551–1558.     

Continuous positive airway pressure reduces risk of motor vehicle crash among drivers with obstructive sleep apnea: systematic review and meta-analysis

Context:

Obstructive sleep apnea (OSA) is associated with an increased risk of motor vehicle crash.

Objective:

We performed a systematic review of the literature concerning the impact of continuous positive airway pressure (CPAP) treatment on motor vehicle crash risk among drivers with OSA. The primary objective was to determine whether CPAP use could reduce the risk of motor vehicle crash among drivers with OSA. A secondary objective involved determining the time on treatment required for CPAP to improve driver safety.

Data Sources:

We searched seven electronic databases (MEDLINE, PubMed (PreMEDLINE), EMBASE, PsycINFO, CINAHL, TRIS, and the Cochrane library) and the reference lists of all obtained articles.

Study Selection:

We included studies (before-after, case-control, or cohort) that addressed the stated objectives. We evaluated the quality of each study and the interplay between the quality, quantity, robustness, and consistency of the evidence. We also tested for publication bias.

Data Extraction:

Data were extracted by two independent analysts. When appropriate, data were combined in a fixed or random effects meta-analysis.

Results:

A meta-analysis of 9 observational studies examining crash risk of drivers with OSA pre- vs. post-CPAP found a significant risk reduction following treatment (risk ratio = 0.278, 95% CI: 0.22 to 0.35; P < 0.001). Although crash data are not available to assess the time course of change, daytime sleepiness improves significantly following a single night of treatment, and simulated driving performance improves significantly within 2 to 7 days of CPAP treatment.

Conclusions:

Observational studies indicate that CPAP reduces motor vehicle crash risk among drivers with OSA.

Citation:

Tregear S; Reston J; Schoelles K; Phillips B. Continuous positive airway pressure reduces risk of motor vehicle crash among drivers with obstructive sleep apnea. SLEEP 2010;33(10):1373-1380.     

Endothelial Function in Normotensive Men with Obstructive Sleep Apnea Before and 6 Months After CPAP Treatment

Study Objectives:

To evaluate endothelium-dependent flow-mediated dilation (FMD) and endothelium–independent nitroglycerin (NTG)-induced dilation of the brachial artery with Doppler ultrasound in patients with obstructive sleep apnea (OSA) and impact of six months of continuous positive airway pressure (CPAP) treatment.

Design:

A prospective, controlled, observational study.

Setting:

Single-site, clinic-based.

Patients:

Twenty-nine normotensive men with OSA (apnea-hypopnea index [AHI], mean ± SD, 60.4 ± 22.1-h), and 17 men without OSA (AHI 2.5 ± 0.6-h).

Interventions:

Six months of CPAP therapy in OSA patients.

Measurements and Results:

FMD was lower in patients with OSA compared with in controls (7.19 ± 1.78 % vs 10.93 ± 2.59 %; P < 0.001) while NTG-induced vasodilation was similar in both groups (13.75 ± 1.01 % vs 14.25 ± 1.83 %; n.s.). An inverse relationship was found between FMD and AHI adjusted for age and body mass index (BMI) (β = − 0.05, P < 0.001). Following 6 months of CPAP treatment in the OSA group, FMD was increased from 7.38 ± 2.06 % to 10.45 ± 1.68; P = 0.001) in 20 patients compliant with the device whereas the corresponding values did not change in the non-user group (7.08 ± 1.50% vs 7.26 ± 1.01%). No significant changes were observed regarding the NTG–induced vasodilation after CPAP compared with the baseline values.

Conclusion:

Our results confirm the previous reports suggesting impaired endothelium-dependent FMD in OSA, and additionally document the sustained improvement in endothelial function after 6 months of CPAP treatment in complaint patients.

Citation:

Bayram NA; Ciftci B; Keles T; Durmaz T; Turhan S; Bozkurt E; Peker Y. Endothelial function in normotensive men with obstructive sleep apnea before and 6 months after CPAP treatment. SLEEP 2009;32(10):1257-1263.     

Effectiveness of a Novel Integrative Online Treatment for Depression (Deprexis): Randomized Controlled Trial

Background

Depression is associated with immense suffering and costs, and many patients receive inadequate care, often because of the limited availability of treatment. Web-based treatments may play an increasingly important role in closing this gap between demand and supply. We developed the integrative, Web-based program Deprexis, which covers therapeutic approaches such as behavioral activation, cognitive restructuring, mindfulness/acceptance exercises, and social skills training.

Objective

To evaluate the effectiveness of the Web-based intervention in a randomized controlled trial.

Methods

There were 396 adults recruited via Internet depression forums in Germany, and they were randomly assigned in an 80:20 weighted randomization sequence to either 9 weeks of immediate-program-access as an add-on to treatment-as-usual (N = 320), or to a 9-week delayed-access plus treatment-as-usual condition (N = 76). At pre- and post-treatment and 6-month follow-up, we measured depression (Beck Depression Inventory) as the primary outcome measure and social functioning (Work and Social Adjustment Scale) as the secondary outcome measure. Completer analyses and intention-to-treat analyses were performed.

Results

Of 396 participants, 216 (55%) completed the post-measurement 9 weeks later. Available case analyses revealed a significant reduction in depression severity (BDI), Cohen’s d = .64 (CI 95% = 0.33 - 0.94), and significant improvement in social functioning (WSA), Cohen’s d = .64, 95% (CI 95% = 0.33 - 0.95). These improvements were maintained at 6-month follow-up. Intention-to-treat analyses confirmed significant effects on depression and social functioning improvements (BDI: Cohen’s d = .30, CI 95% = 0.05 - 0.55; WSA: Cohen’s d = .36, CI 95% = 0.10 - 0.61). Moreover, a much higher percentage of patients in the intervention group experienced a significant reduction of depression symptoms (BDI: odds ratio [OR] = 6.8, CI 95% = 2.90 - 18.19) and recovered more often (OR = 17.3, 95% CI 2.3 - 130). More than 80% of the users felt subjectively that the program had been helpful.

Conclusions

This integrative, Web-based intervention was effective in reducing symptoms of depression and in improving social functioning. Findings suggest that the program could serve as an adjunctive or stand-alone treatment tool for patients suffering from symptoms of depression.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 64953693; http://www.controlled-trials.com/ISRCTN64953693/64953693 (Archived by WebCite at http://www.webcitation.org/5ggzvTJPD)     

Cognitive Function and Sleep Related Breathing Disorders in a Healthy Elderly Population: the Synapse Study

Study Objectives:

Sleep related breathing disorders (SRBD) are risk factors for cognitive dysfunction in middle-aged subjects, but this association has not been observed in the elderly. We assess the impact of SRBD on cognitive performance in a large cohort of healthy elderly subjects.

Design:

Cross-sectional study examining the association between subjective memory test, neuropsychological battery testing and SRBD in the elderly.

Setting:

Community-based sample in home and research clinical settings.

Participants:

827 subjects, 58.5% women, aged 68 y at study entry, participated in the study. All were free of previously diagnosed SRBD, coronary heart disease, and neurological disorders, including stroke and dementia. Clinical interview, neurological assessment, polygraphy, and extensive cognitive testing were conducted for all participants.

Intervention:

N/A

Measurement and Results:

SRBD (apnea-hypopnea index [AHI] > 15 events/h) was diagnosed in 445 (53%) subjects, 167 (37%) of them with AHI > 30. Minimal daytime sleepiness was found in the group; 9.2% of the population had an Epworth Sleepiness Scale score > 10. No significant association was found between AHI, nocturnal hypoxemia, and cognitive scores. Comparison of mild vs severe cases showed a trend toward lower cognitive scores with AHI > 30, affecting delayed recall and Stroop test.

Conclusions:

The impact of undiagnosed SRBD on cognitive function appeared quite limited in a generally older healthy population, and only slightly affected severe cases. The implication of undiagnosed SRBD on the cognitive impairment in elderly subjects remains hypothetical and needs to be prospectively studied.

Clinical Trial Information:

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea (SYNAPSE); Registration #{"type":"clinical-trial","attrs":{"text":"NCT 00766584","term_id":"NCT00766584"}}NCT 00766584 (This study is ongoing, but not recruiting participants.); URL - http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00766584","term_id":"NCT00766584"}}NCT00766584?term=NCT+00766584&rank=1

Citation:

Sforza E; Roche F; Thomas-Anterion C; Kerleroux J; Beauchet O; Celle S; Maudoux D; Pichot V; Laurent B; Barthélémy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the synapse study. SLEEP 2010;33(4):515-521     

Daytime Sleepiness and Driving Performance in Patients with Obstructive Sleep Apnea: Comparison of the MSLT,the MWT,and a Simulated Driving Task

Study Objectives:

To test the reliability of a driving-simulation test for the objective measurement of daytime alertness compared with the Multiple Sleep Latency Test (MSLT) and with the Maintenance of Wakefulness Test (MWT), and to test the ability to drive safely, in comparison with on-road history, in the clinical setting of untreated severe obstructive sleep apnea.

Design:

N/A.

Setting:

Sleep laboratory.

Patients or Participants:

Twenty-four patients with severe obstructive sleep apnea and reported daytime sleepiness varying in severity (as measured by the Epworth Sleepiness Scale).

Interventions:

N/A.

Measurements and Results:

Patients underwent MSLT and MWT coupled with 4 sessions of driving-simulation test on 2 different days randomly distributed 1 week apart. Simulated-driving performance (in terms of lane-position variability and crash occurrence) was correlated with sleep latency on the MSLT and more significantly on the MWT, showing a predictive validity toward the detection of sleepy versus alert patients with obstructive sleep apnea. In addition, patients reporting excessive daytime sleepiness or a history of car crashes showed poorer performances on the driving simulator.

Conclusions:

A simulated driving test is a suitable tool for objective measurement of daytime alertness in patients with obstructive sleep apnea. Further studies are needed to clarify the association between simulated-driving performance and on-road crash risk of patients with sleep disordered breathing.

Citation:

Pizza F; Contardi S; Mondini S; Trentin L; Cirignotta F. Daytime sleepiness and driving performance in patients with obstructive sleep apnea: comparison of the MSLT, the MWT, and a simulated driving task. SLEEP 2009;32(3):382-391.     

Cost-utility and cost-effectiveness of internet-based treatment for adults with depressive symptoms: randomized trial

Background

The effectiveness of Internet-based treatments for depression has been demonstrated; their cost-effectiveness, however, has been less well researched.

Objective

Evaluating the relative cost-utility and cost-effectiveness of (1) Internet-based cognitive behavioral therapy, (2) Internet-based problem-solving therapy, and (3) a waiting list for adults with depressive symptoms.

Methods

A total of 263 participants with clinically significant depressive symptoms were randomized to Internet-based cognitive behavioral therapy (n = 88), Internet-based problem-solving therapy (n = 88), and a waiting list (n = 87). End points were evaluated at the 12-week follow-up.

Results

Cost-utility analysis showed that cognitive behavioral therapy and problem-solving therapy had a 52% and 61% probability respectively of being more acceptable than waiting when the willingness to pay is € 30,000 for one quality-adjusted life-year. When society is prepared to pay € 10,000 for a clinically significant change from depression, the probabilities of cognitive behavioral therapy and problem-solving therapy being more acceptable than waiting are 91% and 89%, respectively. Comparing both Internet-based treatments showed no clear preference for one or the other of the treatments.

Conclusions

Both Internet-based treatments have a high probability of being cost-effective with a modest value placed on clinically significant change in depressive symptoms.

Trial Registration

ISRCTN16823487; http://www.controlled-trials.com/ISRCTN16823487 (Archived by WebCite at http://www.webcitation.org/5u8slzhDE)     

Patients’ Reported Reasons for Non-Use of an Internet-Based Patient-Provider Communication Service: Qualitative Interview Study

Background

The adoption of Internet-based patient–provider communication services (IPPC) in health care has been slow. Patients want electronic communication, and the quality of health care can be improved by offering such IPPCs. However, the rate of enrollment in such services remains low, and the reasons for this are unclear. Knowledge about the barriers to use is valuable during implementation of IPPCs in the health care services, and it can help timing, targeting, and tailoring IPPCs to different groups of patients.

Objective

The goal of our study was to investigate patients’ views of an IPPC that they could use from home to pose questions to nurses and physicians at their treatment facility, and their reported reasons for non-use of the service.

Methods

This qualitative study was based on individual interviews with 22 patients who signed up for, but did not use, the IPPC.

Results

Patients appreciated the availability and the possibility of using the IPPC as needed, even if they did not use it. Their reported reasons for not using the IPPC fell into three main categories: (1) they felt that they did not need the IPPC and had sufficient access to information elsewhere, (2) they preferred other types of communication such as telephone or face-to-face contact, or (3) they were hindered by IPPC attributes such as login problems.

Conclusions

Patients were satisfied with having the opportunity to send messages to health care providers through an IPPC, even if they did not use the service. IPPCs should be offered to the patients at an appropriate time in the illness trajectory, both when they need the service and when they are receptive to information about the service. A live demonstration of the IPPC at the point of enrollment might have increased its use.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139; http://clinicaltrial.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139 (Archived by WebCite at http://www.webcitation.org/6KlOiYJrW).     

The 10-Year Risk of Verified Motor Vehicle Crashes in Relation to Physiologic Sleepiness

Study Objectives:

The purpose of this study was to determine the risk of DMV documented crashes as a function of physiological sleepiness in a population-based sample.

Design:

24-hour laboratory assessment (nocturnal polysomnogram and daytime MSLT) and 10-year crash rate based on DMV obtained accident records.

Participants:

618 individuals (mean age = 41.6 ± 12.8; 48.5% male) were recruited from the general population of southeastern Michigan using random-digit dialing techniques.

Results:

Subjects were divided into 3 groups based on their average MSLT latency (in minutes) as follows: excessively sleepy, 0.0 to ≤ 5.0 (n = 69); moderately sleepy, 5.0 to ≤ 10.0 (n = 204); and alert, > 10 (n = 345). Main outcome measures were DMV data on accidents from 1995-2005. Rates for all accidents in the 3 MSLT groups were: excessively sleepy = 59.4%, moderately sleepy = 52.5%, alert = 47.3%. Excessively sleepy subjects were at significantly greater risk of an accident over the 10-year period compared to alert subjects. A similar relation was observed when we limited the database to those accident victims with severe injury (excessively sleepy = 4.3%, moderately sleepy = 0.5%, alert = 0.6%; P = 0.028). When the victim was the only occupant of the car, subjects in the lowest MSLT group (highest sleepiness) had the greatest crash rate compared with alert individuals (excessively sleepy = 52.2%, moderately sleepy = 42.2%, alert = 37.4%; P = 0.022).

Interventions:

N/A

Conclusions:

These data demonstrate that the MSLT, a physiological measure of sleepiness, is predictive of an increased risk of DMV documented automotive crashes in the general population.

Citation:

Drake C; Roehrs T; Breslau N; Johnson E; Jefferson C; Scofield H; Roth T. The 10-year risk of verified motor vehicle crashes in relation to physiologic sleepiness. SLEEP 2010;33(6):745-752.     

Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

Background

The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress.

Objective

Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones).

Methods

The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation.

Results

Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs CG=0.5%) in chronic “trait” anxiety. A similar pattern was found for coping skills: both treatments were able to significantly increase most coping skills, but only EG participants reported a significant increase (EG=14% vs CG=0.3%) in the Emotional Support skill.

Conclusions

Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment: CBT. Consequently, these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01683617","term_id":"NCT01683617"}}NCT01683617; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01683617","term_id":"NCT01683617"}}NCT01683617 (Archived by WebCite at http://www.webcitation.org/6QnziHv3h).     

Longitudinal Evaluation of Sleep-Disordered Breathing and Sleep Symptoms with Change in Quality of Life: The Sleep Heart Health Study (SHHS)

Study Objectives:

Findings from population studies evaluating the progression and incidence of sleep disordered breathing have shown evidence of a longitudinal increase in the severity of sleep disordered breathing. The present study evaluates the association among changes in sleep disordered breathing, sleep symptoms, and quality of life over time.

Design:

Prospective cohort study. Data were from the Sleep Heart Health Study.

Setting:

Multicenter study.

Participants:

Three thousand seventy-eight subjects aged 40 years and older from the baseline and follow-up examination cycles were included.

Measurements:

The primary outcomes were changes in the Physical Component Summary and Mental Component Summary scales obtained from the Medical Outcomes Study Short-Form Health Survey. The primary exposure was change in the respiratory disturbance index obtained from unattended overnight polysomnograms performed approximately 5 years apart. Other covariates included measures of excessive daytime sleepiness and difficulty initiating and maintaining sleep.

Results:

Mean respiratory disturbance index increased from 8.1 ± 11 SD at baseline to 10.9 ± 14 (P < 0.0001) at follow-up. The mean Physical Component Summary and Mental Component Summary scores were 48.5 and 54.1 at baseline and 46.3 and 54.8 at follow-up. No associations between change in respiratory disturbance index and changes in Physical Component Summary or Mental Component Summary scores were seen. However, worsening of difficulty initiating and maintaining sleep and excessive daytime sleepiness were significantly associated with lower quality of life.

Conclusions:

A slight increase in severity of sleep disordered breathing was seen over 5 years; this was not associated with worsening of quality of life. However, subjective symptoms of quality of sleep and daytime sleepiness were associated with declining quality of life.

Citation:

Silva GE; An MW; Goodwin JL; Shahar E; Redline S; Resnick H; Baldwin CM; Quan SF. Longitudinal evaluation of sleep-disordered breathing and sleep symptoms with change in quality of life: the Sleep Heart Health Study (SHHS). SLEEP 2009;32(8):1049-1057.     

Dietary Supplements in the Management of Hypertension and Diabetes - A Review

Background

The use of alternative therapies like herbs and dietary supplements is very common among hypertensive and diabetic patients all over the globe. Hypertension is a silent disease that causes increase in cardiovascular, cerebrovascular, renal morbidity and mortality whereas diabetic complications cause heart attack, stroke, blindness and kidney disease. These are serious and chronic metabolic disorders that have a significant impact on the health, quality of life, and life expectancy of patients, as well as on the health care systems. Orthodox drugs used for the treatment of hypertension and diabetes produce side effects such as headache, nausea, vomiting, stomach pain, constipation, diarrhea, weakness, fatigue and erectile dysfunction. The need for considering alternate therapies in the form of dietary supplements known to promote good health, having little or no side effects therefore arises.

Materials and methods

This review was carried out using comprehensive and systematic literature reports on the concurrent use of dietary supplements in the management of diabetes and hypertension. Empirical searches were conducted using Google scholar (http://scholar.google.com), and Science Direct (http://www.sciencedirect.com). In addition to these databases, the University database was also used. Searches were also undertaken using keyword combinations such as dietary supplements and the names of the diseases in question.

Result and Discussion

This review chronicled the therapeutic values of vitamins, minerals, amino acids, fruits, vegetables, herbs and other botanicals used as dietary supplements. Results show that these supplements provided better and safe substitutes to toxic and expensive conventional drugs. Generally dietary supplements are free from major side effects, readily available and affordable. It is envisaged that the use of dietary supplement will promote good health and improve the status of hypertensive and diabetic patients.

Conclusion

Medical doctors are therefore encouraged to incorporate dietary supplements into the regimen employed for hypertension and diabetes management.     

Does Subjective Sleepiness Predict Objective Sleep Propensity?

Study Objectives:

Research has shown variability in the correlations observed between subjective sleepiness and objective polysomnographic sleep latency. The present study evaluated whether eliciting subjective judgments of sleepiness after a 1-minute period of quiet with eyes closed would strengthen the relationship between subjective and objective measures.

Design:

Subjective judgments of sleepiness were collected following three 1-minute conditions (eyes-closed, eyes-open fixed gaze, and visual reaction time task) using the Stanford Sleepiness Scale and a visual analogue scale, prior to a measure of polysomnographic sleep latency. For each participant, subjective and objective measures were obtained a total of 12 times half-hourly from 20:00 to 01:30.

Setting:

Sleep laboratory of the Flinders University.

Participants:

Participants were 12 young adult good sleepers.

Results:

Within-subjects correlations between subjective and objective sleepiness across an evening period of increasing sleepiness were generally high (means approximately −0.63) and significant (P < 0.05). Contrary to expectation, there were no differences in correlations among the 3 conditions. Unexpectedly, when the correlations were calculated across subjects, correlations were noticeably weaker (means around −0.42), whereas the correlation means calculated across subjects, controlling for clock time, were close to 0.

Conclusions:

In controlled laboratory conditions, high correlations between subjective and objective measures of sleepiness within subjects were found across a large range of sleepiness (20:00 to 01:30) for all conditions. Calculating correlations within subjects and across a range of the circadian variation in sleepiness contributed substantially to the strength of the relationship found. These results suggest that the variability of prior research findings may be due, at least partly, to the way in which correlations were derived.

Citation:

Short M; Lack L; Wright H. Does subjective sleepiness predict objective sleep propensity? SLEEP 2010;33(1):123-129.     

Narcolepsy with Long Sleep Time: A Specific Entity?

Background:

The classical narcolepsy patient reports intense feelings of sleepiness (with/out cataplexy), normal or disrupted nighttime sleep, and takes short and restorative naps. However, with long-term monitoring, we identified some narcoleptics resembling patients with idiopathic hypersomnia.

Objective:

To isolate and describe a new subtype of narcolepsy with long sleep time).

Setting:

University Hospital

Design:

Controlled, prospective cohort

Participants:

Out of 160 narcoleptics newly diagnosed within the past 3 years, 29 (18%) had a long sleep time (more than 11 h/24 h). We compared narcoleptics with (n = 23) and without (n = 29) long sleep time to 25 hypersomniacs with long sleep time and 20 healthy subjects.

Intervention:

Patients and controls underwent face-to face interviews, questionnaires, human leukocyte antigen (HLA) genotype, an overnight polysomnography, multiple sleep latency tests, and 24-h ad libitum sleep monitoring.

Results:

Narcoleptics with long sleep time had a similar disease course and similar frequencies of cataplexy, sleep paralysis, hallucinations, multiple sleep onset in REM periods, short mean sleep latencies, and HLA DQB1*0602 positivity as narcoleptics with normal sleep time did. However, they had longer sleep time during 24 h, and higher sleep efficiency, lower Epworth Sleepiness Scale scores, and reported their naps were more often unrefreshing. Only 3/23 had core narcolepsy (HLA and cataplexy positive).

Conclusions:

The subgroup of narcoleptics with a long sleep time comprises 18% of narcoleptics. Their symptoms combine the disabilities of both narcolepsy (severe sleepiness) and idiopathic hypersomnia (long sleep time and unrefreshing naps). Thus, they may constitute a group with multiple arousal system dysfunctions.

Citation:

Vernet C; Arnulf I. Narcolepsy with long sleep time: a specific entity? SLEEP 2009;32(9):1229-1235.     

Sleep Disturbance,Daytime Sleepiness,and Neurocognitive Performance in Children with Juvenile Idiopathic Arthritis

Study Objectives:

To compare daytime sleepiness and neurobehavioral performance in children with active and inactive juvenile idiopathic arthritis (JIA), and explore relations among measures of sleep disturbance, daytime sleepiness, and neurobehavioral performance.

Design:

Cross-sectional, comparison.

Setting:

A university-based research sleep laboratory.

Participants:

Seventy (70) children 6-11 years of age with active or inactive JIA.

Measurements and Results:

Self-reported daytime sleepiness, multiple sleep latency tests (MSLTs), and computerized neurobehavioral performance test scores were obtained after 2 nights of polysomnography. Children with active disease (mean physician global rating score = 2.9 ± 1.9 SD) showed shorter mean MSLT latency (15 ± 6.0 min) than those with inactive disease (16.5 ± 5.5 min, P < 0.03). Scores on neurobehavioral performance tests showed no group differences. However, number of wake bouts predicted sustained visual attention (rapid visual processing, P < 0.05) and apnea hypopnea index (AHI) predicted reaction time (P < 0.0001), after controlling for age, IQ, medication, and disease status.

Conclusion:

Indices of sleep disturbance were associated with validated tests of neurobehavioral performance in JIA, regardless of disease activity. Additional research is needed about the extent of sleep disturbances in relation to neurocognitive performance in JIA and compared to healthy children.

Citation:

Ward TM; Archbold K; Lentz M; Ringold S; Wallace CA; Landis CA. Sleep disturbance, daytime sleepiness, and neurocognitive performance in children with juvenile idiopathic arthritis. SLEEP 2010;33(2):252-259.