Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy

Study ObjectivesDigital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.MethodsEligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.ResultsIndividuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.ConclusionsAt the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.     

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission

Study ObjectivesSleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.MethodsThis secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi—Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.ResultsAt post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).ConclusionsFindings demonstrate that an Internet-delivered CBT-I program can effectively increase users’ sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT00328250","term_id":"NCT00328250"}}NCT00328250     

Treating insomnia symptoms with medicinal cannabis: a randomized,crossover trial of the efficacy of a cannabinoid medicine compared with placebo

Study ObjectivesThis randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).MethodsCo-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.ResultsTwenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (−5.07 units [95% CI: −7.28 to −2.86]; p = 0.0001) and self-reported SOL (−8.45 min [95% CI: −16.33 to −0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (−10.2 min [95% CI: −16.2 to −4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).ConclusionsTwo weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.Clinical TrialANZCTR; anzctr.org.au; ACTRN12618000078257.     

Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic

Study ObjectivesStressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic.MethodsCOVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016–2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic.ResultsInsomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition.ConclusionsThose who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT02988375","term_id":"NCT02988375"}}NCT02988375     

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Sleepless in COVID-19: racial disparities during the pandemic as a consequence of structural inequity

Study ObjectivesInsomnia has been on the rise during the 2019 coronavirus disease (COVID-19) pandemic, which may disproportionately affect racial minorities. This study characterized racial disparities in insomnia during the pandemic and evaluated mechanisms for such disparities.MethodsParticipants included 196 adults (48 Black) from a 2016–2017 clinical trial of insomnia treatment who were reevaluated in April 2020. Race was evaluated as a predictor of change in insomnia, impact of COVID-19, and COVID-19 stress. Mediation models using the PRODCLIN method evaluated the extent to which: (1) COVID-19 impact accounted for Black-White disparities in change in insomnia, and (2) COVID-19 stress accounted for associations between discrimination and change in insomnia.ResultsIncreases in insomnia symptoms during COVID-19 were greater in Black compared to White participants, with 4.3 times the odds of severe insomnia (Insomnia Severity Index ≥ 22). Symptom severity was associated with pre-pandemic experiences of discrimination. Black participants were also disproportionately impacted by COVID-19, with twice the odds of irreparable loss of income/employment and four times the rate of COVID-19 diagnoses in their sociofamilial network compared to White participants. The disproportionate impact of COVID-19 accounted for 69.2% of the relationship between race and change in insomnia severity, and COVID-19 related stress accounted for 66.5% of the relationship between prior history of racial discrimination and change in insomnia severity.ConclusionsBlack-White disparities in insomnia severity during COVID-19 may be driven by structural inequities resulting in the disproportionate impact of COVID-19 on Black Americans. Results lend support for the minority stress model in the context of sleep health.Clinical Trial RegistrationSleep to Prevent Evolving Affecting Disorders (SPREAD). NCT number: NCT02988375. https://clinicaltrials.gov/ct2/show/NCT02988375.     

The acute effects of aerobic exercise on sleep in patients with unipolar depression: a randomized controlled trial

Study ObjectivesInsomnia increases the risk of negative disease trajectory, relapse, and suicide in patients with depression. We aimed at investigating the effects of a single bout of aerobic exercise, performed after 02:00 pm, on the subsequent night’s sleep in patients with depression.MethodsThe study was designed as a two-arm parallel-group, randomized, outcome assessor-blinded, controlled, superiority trial. Patients between 18 and 65 years of age with a primary diagnosis of unipolar depression were included. The intervention was a single 30-minute bout of moderate aerobic exercise. The control group sat and read for 30 minutes. The primary outcome was sleep efficiency measured by polysomnography. Secondary outcomes were other polysomnographic variables, subjective sleep quality, daytime sleepiness, mood states, and adverse events.ResultsNinety-two patients were randomized to the exercise (N = 46) or control group (N = 46). There were no clinically relevant differences at baseline. Intent-to-treat analysis ANCOVA of follow-up sleep efficiency, adjusted for baseline levels and minimization factors, did not detect a significant effect of the allocation (β = −0.93, p = 0.59). There was no evidence for significant differences between both groups in any other objective or subjective sleep outcomes, daytime sleepiness, or adverse events. The intervention had an immediate positive effect on mood states, including depressiveness (β = −0.40, p = 0.003).ConclusionsThis is the first trial to study the effects of a single bout of aerobic exercise on sleep in patients with depression to the best of our knowledge. Aerobic exercise had no effect on sleep efficiency but had a strong beneficial effect on mood and did not increase adverse outcomes. These results add to the growing body of evidence that, contrary to sleep hygiene recommendations, exercise after 02:00 pm is not detrimental for sleep.Clinical Trial RegistrationClinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT03673397. Protocol registered on September 17, 2018.     

Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis

Study ObjectivesPoor sleep quality affects nearly one-third of breast cancer survivors and is associated with insulin resistance. The purpose of this secondary analysis was to examine the effects of a 16-week exercise intervention on patient-reported sleep quality among breast cancer survivors and assess whether changes in patient-reported sleep quality were associated with cardiometabolic biomarkers. We explored Hispanic ethnicity as a moderator of the effects of exercise on patient-reported sleep quality.MethodsBreast cancer survivors who were overweight or obese were randomized to exercise (n = 50) or usual care (n = 50). The 16-week intervention included aerobic and resistance exercise. Patient-reported sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and biomarkers of cardiometabolic health were assessed at baseline and post-intervention. Within- and between-group differences were assessed using general linear models repeated-measures analyses of variance and mixed-model repeated-measure analysis, respectively. Associations between changes in PSQI and cardiometabolic biomarkers were computed using Pearson correlations. Linear mixed-models were used to evaluate effect modification by ethnicity.ResultsParticipants were 52 ± 10.4 years old, and over half were of Hispanic ethnicity. As compared to usual care, PSQI global scores improved significantly in the exercise group (mean between-group difference −2.2; 95% CI −3.2 to −0.6). Change in PSQI was inversely associated with changes in all cardiometabolic biomarkers (p < 0.01) among the exercise group. Ethnicity was found to moderate the effects of exercise training on global sleep quality (p < 0.001).ConclusionsAn aerobic and resistance exercise intervention effectively improved patient-reported sleep quality in breast cancer survivors. Hispanic ethnicity as a moderator showed greater improvement in patient-reported sleep indicating Hispanic versus non-Hispanic breast cancer survivors may derive larger sleep benefits.Clinical Trail Information{"type":"clinical-trial","attrs":{"text":"NCT01140282","term_id":"NCT01140282"}}NCT01140282.     

Eszopiclone versus zopiclone in the treatment of insomnia

OBJECTIVE:To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia.METHODS:This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01100164","term_id":"NCT01100164"}}NCT01100164.RESULTS:The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group.CONCLUSION:Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography.     

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial

Background

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I.

Aim

To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia.

Design and setting

Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand.

Method

Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined ‘insomnia remission’ treatment response was calculated.

Results

Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference −2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects.

Conclusion

SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.     

Sleep symptomatology is associated with greater subjective cognitive concerns: findings from the community-based Healthy Brain Project

Study ObjectivesTo examine if sleep symptomatology was associated with subjective cognitive concerns or objective cognitive performance in a dementia-free community-based sample.MethodsA total of 1,421 middle-aged participants (mean ± standard deviation = 57 ± 7; 77% female) from the Healthy Brain Project completed the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale to measure sleep quality, insomnia symptom severity, and daytime sleepiness, respectively. Participants were classified as having no sleep symptomatology (normal scores on each sleep measure), moderate sleep symptomatology (abnormal scores on one sleep measure), or high sleep symptomatology (abnormal scores on at least two sleep measures), using established cutoff values. Analysis of covariance was used to compare objective cognitive function (Cogstate Brief Battery) and subjective cognitive concerns (Modified Cognitive Function Instrument) across groups.ResultsFollowing adjustments for age, sex, education, mood, and vascular risk factors, persons classified as having high sleep symptomatology, versus none, displayed more subjective cognitive concerns (d = 0.24) but no differences in objective cognitive performance (d = 0.00–0.18). Subjective cognitive concerns modified the association between sleep symptomatology and psychomotor function. The strength of the relationship between high sleep symptomatology (versus none) and psychomotor function was significantly greater in persons with high as compared with low cognitive concerns (β ± SE = −0.37 ± 0.16; p = 0.02).ConclusionsMore severe sleep symptomatology was associated with greater subjective cognitive concerns. Persons reporting high levels of sleep symptomatology may be more likely to display poorer objective cognitive function in the presence of subjective cognitive concerns.     

A 12-Week,Randomized, Double-Blind,Placebo-Controlled Study Evaluating the Effect of Eszopiclone 2 mg on Sleep/Wake Function in Older Adults with Primary and Comorbid Insomnia

Background:

Longer-term pharmacologic studies for insomnia in older individuals are sparse.

Objective:

To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia.

Methods:

Participants (65–85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) ≤ 6 h, and wake time after sleep onset (WASO) ≥ 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, well-being, ability to function) were assessed. AEs were monitored.

Results:

Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values ≤ 0.01), indicating no rebound. The most common AEs (≥ 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%).

Conclusion:

In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and were maintained for 3 months, with no evidence of rebound insomnia following discontinuation. The 12 weeks of treatment were well tolerated.

Clinical Trial Information:

A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia; Registration #{"type":"clinical-trial","attrs":{"text":"NCT00386334","term_id":"NCT00386334"}}NCT00386334; URL - http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00386334","term_id":"NCT00386334"}}NCT00386334?term=eszopiclone&rank=24

Citation:

Ancoli-Israel S; Krystal AD; McCall WV; Schaefer K; Wilson A; Claus R; Rubens R; Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. SLEEP 2010;33(2):225-234.     

The Mediating Effect of Insomnia on the Relationship between Panic Symptoms and Depression in Patients with Panic Disorder

BackgroundThis study aimed to determine if sleep disturbances may mediate the relationship between panic symptoms and depression in patients with panic disorder (PD).MethodsElectronic medical records were retrospectively reviewed for 110 consecutive patients with diagnosed PD in an outpatient clinic between October 2018 and December 2019. Measurements include the PD Severity Scale, Beck Depression Inventory-II (BDI-II) and Insomnia Severity Index (ISI). Statistical analyses were performed to assess any potential relationship between PD, insomnia and depression.ResultsOf the PD patients, 88 (80%) and 89 (80.9%) had comorbid depression (BDI-II ≥ 14) and insomnia (Korean version of the ISI ≥ 8), respectively. In a mediation model using insomnia as the mediating variable, the total effect of panic symptom severity on depression was significant (t = 7.23, P < 0.001). There were significant effects of panic symptoms on insomnia (t = 4.62, P < 0.001) and of insomnia on depression (t = 6.69, P < 0.001). The main effect of panic symptom severity on depression was also significant, after controlling for the effect of insomnia (t = 5.10, P < 0.001), suggesting partial mediation.ConclusionBoth depressive symptoms and insomnia are common in patients with PD and depression was partially mediated by insomnia in these patients. These results suggest that an intervention for insomnia in patients with PD might help prevent the development of depression.     

Insomnia with objective short sleep duration is associated with cognitive impairment: a first look at cardiometabolic contributors to brain health

Study ObjectivesInsomnia with objective short sleep duration has been previously associated with adverse cardiometabolic health outcomes as well as poorer cognitive performance in otherwise noncognitively impaired adults. However, studies demonstrating an increased prevalence of cognitive impairment (CI) in this insomnia phenotype are lacking.MethodsWe analyzed data from Penn State Adult Cohort (N = 1,524; 48.9 ± 13.4 years; 53.4% women). Self-reported sleep difficulty was defined as normal sleep (n = 899), poor sleep (n = 453), and chronic insomnia (n = 172). Objective short sleep duration was defined as less than 6-h of sleep, based on in-lab, 8-h polysomnography. CI (n = 155) and possible vascular cognitive impairment (pVCI, n = 122) were ascertained using a comprehensive neuropsychological battery. Analyses adjusted for age, sex, race, education, body mass index, apnea/hypopnea index, smoking, alcohol, psychoactive medication, and mental and physical health problems.ResultsParticipants who reported poor sleep or chronic insomnia and slept objectively less than 6 hours were associated with a 2-fold increased odds of CI (OR = 2.06, 95% confidence limits [CL] = 1.15–3.66 and OR = 2.18, 95% CL = 1.07–4.47, respectively) and of pVCI (OR = 1.94, 95% CL = 1.01–3.75 and OR = 2.33, 95% CL = 1.07–5.06, respectively). Participants who reported poor sleep or chronic insomnia and slept objectively more than 6 hours were not associated with increased odds of either CI (OR = 0.72, 95% CL = 0.30–1.76 and OR = 0.75, 95% CL = 0.21–2.71, respectively) or pVCI (OR = 1.08, 95% CL = 0.42–2.74 and OR = 0.76, 95% CL = 0.16–3.57, respectively).ConclusionsInsomnia with objective short sleep duration is associated with an increased prevalence of CI, particularly as it relates to cardiometabolic health (i.e. pVCI). These data further support that this insomnia phenotype may be a more biologically severe form of the disorder associated with cardiovascular, cerebrovascular, and neurocognitive morbidity.     

Evening binge alcohol disrupts cardiovagal tone and baroreflex function during polysomnographic sleep

Study ObjectivesBinge alcohol consumption is associated with increased cardiovascular risk. The effects of evening binge alcohol consumption (i.e. 4–5 beverages within 2 h) on the vagal components of HRV and cardiovagal baroreflex sensitivity (cvBRS) during sleep remain largely equivocal. The present study examined the effects of evening binge alcohol consumption on nocturnal cardiac vagal tone and baroreflex sensitivity during stage N2, slow wave (SWS), and rapid eye movement (REM) sleep. We hypothesized that evening binge drinking would reduce HRV and cvBRS in each sleep stage.MethodsFollowing a familiarization night within the laboratory, twenty-three participants were examined following a night of binge alcohol consumption and a fluid control (randomized, crossover design). A quality nocturnal beat-to-beat blood pressure signal was obtained in both conditions in 16 participants (seven men, nine women; 25 ± 1 years).ResultsBinge drinking reduced both the high frequency (HF) and time-domain components (i.e. pNN50 and RMSSD) of HRV in stage N2 sleep, SWS, and REM. In addition, cvBRS up-up (vagal activation) was reduced following binge alcohol consumption in stage N2 (21 ± 3 vs. 15 ± 3 ms/mmHg, p = 0.035) and REM (15[11–28] vs. 11[9–18] ms/mmHg, p = 0.009). Binge alcohol consumption reduced cvBRS down-down (vagal withdrawal) in stage N2 (23 ± 2 vs. 14 ± 2 ms/mmHg, p < 0.001), SWS (20[14–30] vs. 14[9–17] ms/mmHg, p = 0.022), and REM (14[11–24] vs. 10[7–15] ms/mmHg, p = 0.006).ConclusionsEvening binge alcohol consumption disrupts cardiac vagal tone and baroreflex function during nearly all sleep stages. These findings provide mechanistic insight into the potential role of binge drinking and alcohol abuse on cardiovascular risk.Clinical Trials DetailsAlcohol and Neural Cardiovascular Control in Binge Drinkers, www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT03567434","term_id":"NCT03567434"}}NCT03567434, {"type":"clinical-trial","attrs":{"text":"NCT03567434","term_id":"NCT03567434"}}NCT03567434.     

Actigraphy in the Assessment of Insomnia: A Quantitative Approach

Study Objective:

The lack of quantitative criteria for identifying insomnia using actigraphy represents an unresolved limit for the use of actigraphy in a clinical setting. The current study was conducted to evaluate the most efficient actigraphic parameter in the assessment of insomnia and to suggest preliminary quantitative actigraphic criteria (QAC).

Participants and Measurements:

Performing a retrospective study we recovered 408 actigraphic records from 3 sleep measure databases: 2 regarding insomnia patients (n = 126) and one normal sleepers (n = 282). We compared the 2 samples analyzing the following actigraphic sleep parameters: time in bed (TIB), sleep onset latency (SOL), total sleep time (TST), wake after sleep onset (WASO), sleep efficiency percentage (SE%), number of awakenings longer than 5 minutes (NA > 5) and mean motor activity (MA). Moreover, a linear discriminant function (LDF) was developed to identify and combine the most useful actigraphic sleep parameters to separate insomnia patients from normal sleepers. Using Youden index we calculated the preliminary QAC for each actigraphic sleep parameter and for LDF. Receiver operator characteristic (ROC) curves for classifying the accuracy of QAC were performed.

Results:

All sleep parameters recorded by actigraphy significantly differentiated the 2 groups, except TIB. An LDF analysis showed that the most useful combination of actigraphic sleep parameters to assess insomnia was TST, SOL, and NA > 5, which obtained the best ROC and the best balance between positive and negative predictive values compared to any single actigraphic parameter.

Conclusion:

Actigraphy provided a satisfactory objective measurement of sleep quality in insomnia patients. The combination of TST, SOL, and NA > 5 proved the best way to assess insomnia using actigraphy. Acknowledging that the lack of a technological standard and some methodological limitations prevent us generalizing our results, we recommend additional studies on larger populations using different actigraph models.

Citation:

Natale V; Plazzi G; Martoni M. Actigraphy In The Assessment Of Insomnia: A Quantitative Approach. SLEEP 2009;32(6):767–771.     

Cyclic alternating pattern in children with obstructive sleep apnea and its relationship with adenotonsillectomy,behavior, cognition,and quality of life

Study ObjectivesTo determine in children with obstructive sleep apnea (OSA) the effect of adenotonsillectomy (AT) on the cyclic alternating pattern (CAP) and the relationship between CAP and behavioral, cognitive, and quality-of-life measures.MethodsCAP parameters were analyzed in 365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT), randomized to either early AT (eAT) or watchful waiting with supportive care (WWSC). We also analyzed CAP in a subgroup of 72 children with moderate OSA (apnea–hypopnea index > 10) that were part of the CHAT sample. Causal mediation analysis was performed to determine the independent effect of changes in CAP on selected outcome measures.ResultsAt baseline, a higher number of A1 phases per hour of sleep was significantly associated with worse behavioral functioning (caregiver Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC): ρ = 0.24, p = 0.042; caregiver Conners’ Rating Scale Global Index: ρ = 0.25, p = 0.036) and lower quality of life (OSA-18: ρ = 0.27, p = 0.022; PedsQL: ρ = −0.29, p = 0.015) in the subgroup of children with moderate OSA, but not across the entire sample. At 7-months follow-up, changes in CAP parameters were comparable between the eAT and WWSC arms. CAP changes did not account for significant proportions of variations in behavioral, cognitive, and quality-of-life performance measures at follow-up.ConclusionsWe show a significant association between the frequency of slow, high-amplitude waves with behavioral functioning, as well as the quality of life in children with moderate OSA. Early AT in children with mild-to-moderate OSA does not alter the microstructure of nonrapid eye movement sleep compared with watchful waiting after an approximately 7-month period of follow-up.Clinical TrialThe study “A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome” was registered at Clinicaltrials.gov (#{"type":"clinical-trial","attrs":{"text":"NCT00560859","term_id":"NCT00560859"}}NCT00560859).     

Effect of trataka (yogic gazing) on insomnia severity and quality of sleep in people with insomnia

IntroductionInsomnia or sleeplessness is a common disorder associated with morbidity and poor quality of life. Trataka is one of the six cleansing techniques of yoga. Literature suggests that trataka could help in relieving insomnia. A study was conducted to evaluate the effect of trataka on insomnia severity and quality of sleep (QoS) in people with insomnia.Materials and MethodsTwenty-nine participants with insomnia were recruited, who underwent trataka (45 minutes per day daily) for a period of 10 days. Insomnia severity and QoS were assessed before and after the intervention using the Insomnia Severity Index (ISI) and The Pittsburgh Sleep Quality Index (PSQI), respectively.ResultsThis study showed a significant reduction in ISI score and PSQI global score and its associated subscale scores except sleep medication scores after the intervention.ConclusionTrataka may be considered as a treatment modality in reducing insomnia severity and in improving QoS in people with insomnia.     

Patterns of concomitant prescription,over-the-counter and natural sleep aid use over a 12-month period: a population based study

Study ObjectivesConcomitant patterns of sleep aid use may provide insight for understanding the transition to chronic sleep medication use. Therefore, we sought to characterize the trajectories of concomitant natural product (NP), over-the-counter (OTC), and prescribed (Rx) sleep aid use in a population-based sample over 12-months.MethodsSelf-reported data on the use of NP, OTC, and Rx sleep aids were extracted from a Canadian longitudinal study on the natural history of insomnia (N = 3416, M age = 49.7 ± 14.7 years old; 62% women) at baseline, 6-month, and 12-month. Latent class growth modeling was used to identify latent class trajectories using MPlus Version 7. Participants completed a battery of clinical measures: Ford Insomnia Response to Stress Test, abbreviated Dysfunctional Beliefs and Attitudes about Sleep Scale, Beck Depression Inventory, Insomnia Severity Index and, the Pittsburgh Sleep Quality Index. Associations between class membership and baseline covariates were evaluated.ResultsConcurrent sleep aid use fell into six distinct latent class trajectories over a 12-month period: Minimal Use (74.5%), Rx-Dominant (11.3%), NP-Dominant (6.3%), OTC-Dominant (4.3%), Rx-NP-Dominant (2.4%), and Rx-OTC-Dominant (1.1%). The three latent classes with prominent prescribed agent use predicted greater incidence of healthcare professional consultations for their sleep (p < 0.05), poorer sleep quality (p < 0.001), elevated dysfunctional sleep beliefs (p < 0.001), and sleep reactivity (p < 0.001). Compared to the other four latent classes, clinical profiles of Rx-NP-dominant and Rx-OTC-dominant groups endorsed greater severity across measures.ConclusionsPatterns of sleep aid use may provide insight for identifying individuals who may be vulnerable to inappropriate self-medicating practices.     

Mendelian randomization highlights insomnia as a risk factor for pain diagnoses

Study ObjectiveInsomnia has been linked to acute and chronic pain conditions; however, it is unclear whether such relationships are causal. Recently, a large number of genetic variants have been discovered for both insomnia and pain through genome-wide association studies (GWASs) providing a unique opportunity to examine the evidence for causal relationships through the use of the Mendelian randomization paradigm.MethodsTo elucidate the causality between insomnia and pain, we performed bidirectional Mendelian randomization analysis in FinnGen, where clinically diagnosed ICD-10 categories of pain had been evaluated. In addition, we used measures of self-reported insomnia symptoms. We used endpoints for pain in the FinnGen Release 5 (R5) (N = 218,379), and a non-overlapping sample for insomnia (UK Biobank (UKBB) and 23andMe, N = 1,331,010 or UKBB alone N = 453,379). We assessed the robustness of results through conventional Mendelian randomization sensitivity analyses.ResultsGenetic liability to insomnia symptoms increased the odds of reporting pain (odds ratio (OR) [95% confidence interval (CI)] = 1.47 [1.38–1.58], p = 4.12 × 10⁻²⁸). Manifested pain had a small effect on increased risk for insomnia (OR [95% CI] = 1.04 [1.01–1.07], p < 0.05). Results were consistent in sensitivity analyses.ConclusionsOur findings support a bidirectional causal relationship between insomnia and pain. These data support a further clinical investigation into the utility of insomnia treatment as a strategy for pain management and vice versa.