Effect of Placebo Conditions on Polysomnographic Parameters in Primary Insomnia: A Meta-Analysis

Winkler, Alexander W.; Rief, Winfried

doi:10.5665/sleep.4742

Cited by 39 publications

(43 citation statements)

References 64 publications

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“…This effect may be ascribable to expectancy or the effects of increasing sleep opportunity (extending TIB) over time. In the case of the former, this is in line with recent studies that demonstrate strong subjective responses to placebos in the treatment of insomnia 34,35 and highlights the importance of patient expectancy on outcomes in medication trials.…”

Section: Discussionsupporting

confidence: 87%

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors

et al. 2016

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Study Objectives This study involves the analysis of a secondary outcome of a trial examining whether cognitive behavior therapy for insomnia (CBT-I), a wake-promoting medication (armodafinil), or both results in greater improvement in prospectively assessed sleep continuity and daytime sleepiness than a placebo-alone group among a heterogeneous group of cancer survivors. Whether or not armodafinil alone, and/or when combined with CBT-I, affected adherence with CBT-I was evaluated. Design This study is a randomized, placebo-controlled, clinical trial. Setting This study was conducted at two northeastern academic medical centers. Participants Eighty-eight cancer survivors with chronic insomnia were recruited between October 2008 and November 2012. Participants were assigned to one of four conditions: 1) CBT-I and placebo (CBTI+P); 2) CBT-I and armodafinil (CBT-I+A); 2) armodafinil alone (ARM); or 4) placebo alone (PLA). Interventions CBT-I was delivered in seven weekly individual therapy sessions (three in person, four via telephone). The armodafinil dosage was 50 mg BID. Measurements and Results Sleep continuity was measured with daily sleep diaries assessing sleep latency (SL), wake after sleep onset (WASO), and total sleep time (TST). The Epworth Sleepiness Scale (ESS) measured daytime sleepiness. Compared to the PLA group, the CBT+P and CBT+A groups reported a significant reduction in SL with effect sizes of 0.67 and 0.58, respectively. A significant reduction was observed in WASO in the CBT+A group with an effect size of 0.64. An increasing trend of TST was observed in the CBT+P, CBT+A, and PLA groups, but not in the ARM group. No statistically significant reductions in daytime sleepiness (ESS) were observed for any of the groups. Conclusion CBT-I alone and in combination with armodafinil caused significant improvement in sleep continuity. The addition of armodafinil did not appear to improve daytime sleepiness or enhance adherence to CBT-I.

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Section: Discussionsupporting

confidence: 87%

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors

et al. 2016

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“…The increases in SE, ranging from approximately 5% at 1 mg to 10% at 25 mg, indicate that during the 8-hour sleep opportunity evaluated, subjects slept an average of approximately 24 to 48 minutes longer than those who received placebo. These changes were larger than for placebo at all doses of lemborexant, even with the expected large placebo response, [23][24][25] and were maintained at the end of 15 nights of treatment for lemborexant dose groups ≥ 2.5 mg.…”

Section: Discussionmentioning

confidence: 74%

Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study

Murphy

Moline

Mayleben³

et al. 2017

Journal of Clinical Sleep Medicine

265

105

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Study Objectives: To identify dose(s) of lemborexant that maximize insomnia treatment efficacy while minimizing next-morning residual sleepiness and evaluate lemborexant effects on polysomnography (PSG) measures (sleep efficiency [SE], latency to persistent sleep [LPS], and wake after sleep onset [WASO]) at the beginning and end of treatment. Methods: Adults and elderly subjects with insomnia disorder per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition were enrolled in a multicenter, randomized, double-blind, placebo-controlled, Bayesian, adaptive, parallel-group study, receiving lemborexant (1, 2.5, 5, 10, 15, 25 mg) or placebo for 15 nights. Efficacy assessments included a utility function that combined efficacy (SE) and safety (residual morning sleepiness as measured by Karolinska Sleepiness Scale [KSS]), PSG measures, and sleep diary. Safety assessments included KSS, Digit Symbol Substitution Test, computerized reaction time tests, and adverse events (AEs). Results: A total of 616 subjects were screened; 291 were randomized. Baseline characteristics were similar between lemborexant groups and placebo (~63% female, median age: 49.0 years). The study was stopped for early success after the fifth interim analysis when the 15-mg dose met utility index/KSS criteria for success; 3 other doses also met the criteria. Compared with placebo, subjects showed significant improvements in SE, subjective SE, LPS, and subjective sleep onset latency at the beginning and end of treatment for lemborexant doses ≥ 5 mg (P < .05). WASO and subjective WASO showed numerically greater improvements for doses > 1 mg. AEs, mostly mild to moderate, included dose-related somnolence. Conclusions: Lemborexant doses ranging from 2.5-10 mg provided efficacy for the treatment of insomnia while minimizing next-morning residual sleepiness.

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“…In randomized clinical trials, patients receiving placebo treatment typically achieve results that are almost equivalent to the response of the active intervention group. This has been shown not only for patient reported outcomes, such as pain and depression, but also for objectively assessed biological parameters such as immune reactions (Schedlowski et al, 2015), cardiovascular reactions (Meissner, 2008), or polysomnographic assessments of pain and sleep variables (Winkler and Rief, 2015). …”

Section: Introductionmentioning

confidence: 99%

Can Psychological Expectation Models Be Adapted for Placebo Research?

Rief

Petrie

2016

Front. Psychol.

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Placebo responses contribute substantially to the effect and clinical outcome of medical treatments. Patients' expectations have been identified as one of the major mechanisms contributing to placebo effects. However, to date a general theoretical framework to better understand how patient expectations interact with features of medical treatment has not been developed. In this paper we outline an expectation model that can be used as framework for experimental studies on both placebo and nocebo mechanisms. This model is based on psychological concepts of expectation development, expectation maintenance, and expectation change within the typical paradigms used in placebo research. This theoretical framework reflects the dynamic aspects of the interaction between expectations and medical treatment, and offers a platform to combine psychological and neurophysiological research activities. Moreover, this model can be used to identify important future research questions. For example, we argue that the dynamic processes of expectation maintenance vs. expectation changes are not sufficiently addressed in current research on placebo mechanisms. Therefore, the question about how to change and optimize patients' expectations prior to treatment should be a special focus of future clinical research.

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Effect of Placebo Conditions on Polysomnographic Parameters in Primary Insomnia: A Meta-Analysis

Abstract: In light of these strong placebo responses, future studies should investigate how to exploit placebo mechanisms in clinical practice.

Cited by 39 publications

References 64 publications

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors

Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study

Can Psychological Expectation Models Be Adapted for Placebo Research?

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