Sleep Restriction for Insomnia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
Must not be taking: Sleeping pills, Antidepressants
Disqualifiers: Left-handedness, Ambidexterity, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions.
(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any drugs that could affect sleep or cognitive functioning, such as prescription sleeping pills or antidepressants.
Is sleep restriction therapy safe for humans?
The safety data for sleep restriction therapy is limited, with few studies addressing potential risks. Some research indicates that daytime sleepiness and impaired driving performance may occur during the acute phase of therapy.
12345How does sleep restriction treatment for insomnia differ from other treatments?
Sleep restriction treatment for insomnia is unique because it involves deliberately limiting the time spent in bed to improve sleep efficiency and reduce insomnia symptoms. Unlike other treatments, it focuses on consolidating sleep by initially restricting sleep time and gradually increasing it as sleep quality improves.
34567Eligibility Criteria
This trial is for right-handed individuals who can follow the study's rules, avoid alcohol and drugs during the study, and have normal or corrected-to-normal vision. It's not for those using medications affecting sleep or cognition like sleeping pills or antidepressants.Inclusion Criteria
Willing to refrain from alcohol and recreational drugs for the duration of the protocol
Willing and able to meet inclusion criteria for fMRI scanning
Willing and able to follow the protocol
+1 more
Exclusion Criteria
I am not taking any medication that affects my sleep or thinking.
You are left-handed or can use both hands equally.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Baseline Assessment
Baseline behavioral ratings to emotional stimuli with and without emotion regulation strategies
1 day
1 visit (in-person)
Sleep Restriction
Healthy participants are sleep restricted to 4 hours of sleep for 3 consecutive days before participating in an emotion regulation task during fMRI scanning
3 days
3 visits (in-person)
Follow-up
Participants are monitored for changes in emotional regulation and neural responses after sleep restriction or normal sleep
3-6 days
1 visit (in-person)
Participant Groups
The study tests how three nights with only four hours of sleep affect emotion processing compared to people with Insomnia Disorder and those with regular sleep. It looks at behavior and brain activity related to emotions when sleep-deprived or diagnosed with insomnia.
3Treatment groups
Active Control
Group I: Patients with Insomnia DisorderActive Control1 Intervention
Patients with Insomnia Disorder will also be recruited and will be permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning
Group II: Normal SleepActive Control1 Intervention
Normal Sleep - Healthy participants are permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning
Group III: Sleep RestrictionActive Control1 Intervention
Healthy Participants are sleep restricted to 4 hours of sleep for 3 consecutive days before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical CenterLead Sponsor
References
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial. [2023]Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented.
Daytime sleepiness, driving performance, reaction time and inhibitory control during sleep restriction therapy for Chronic Insomnia Disorder. [2019]Sleep restriction therapy (SRT) is a largely untested single treatment component of cognitive-behaviour therapy for insomnia. To date, the evidence for contraindications for SRT is limited to very few studies. The present study investigated the objective and subjective daytime consequences during the acute phase of SRT for adults diagnosed with Chronic Insomnia Disorder.
The evidence base of sleep restriction therapy for treating insomnia disorder. [2022]Sleep restriction therapy is routinely used within cognitive behavioral therapy to treat chronic insomnia. However, the efficacy for sleep restriction therapy as a standalone intervention has yet to be comprehensively reviewed. This review evaluates the evidence for the use of sleep restriction therapy in the treatment of chronic insomnia. The literature was searched using web-based databases, finding 1344 studies. Twenty-one were accessed in full (1323 were deemed irrelevant to this review). Nine were considered relevant and evaluated in relation to study design using a standardized study checklist and levels of evidence. Four trials met adequate methodological strength to examine the efficacy of therapy for chronic insomnia. Weighted effect sizes for self-reported sleep diary measures of sleep onset latency, wake time after sleep onset, and sleep efficiency were moderate-to-large after therapy. Total sleep time indicated a small improvement. Standalone sleep restriction therapy is efficacious for the treatment of chronic insomnia for sleep diary continuity variables. Studies are insufficient to evaluate the full impact on objective sleep variables. Measures of daytime functioning in response to therapy are lacking. Variability in the sleep restriction therapy implementation methods precludes any strong conclusions regarding the true impact of therapy. A future research agenda is outlined.
Towards standardisation and improved understanding of sleep restriction therapy for insomnia disorder: A systematic examination of CBT-I trial content. [2018]Sleep restriction therapy is a core element of contemporary cognitive-behavioural therapy for insomnia and is also effective as a single-component therapeutic strategy. Since its original description, sleep restriction therapy has been applied in several different ways, potentially limiting understanding of key therapeutic ingredients, mode of action, evidence synthesis, and clinical implementation. We sought to examine the quality of reporting and variability in the application of sleep restriction therapy within the context of insomnia intervention trials. Systematic literature searches revealed 88 trials of cognitive-behavioural therapy/sleep restriction therapy that met pre-defined inclusion/exclusion criteria. All papers were coded in relation to their description of sleep restriction therapy procedures. Findings indicate that a large proportion of papers (39%) do not report any details regarding sleep restriction therapy parameters and, for those papers that do, variability in implementation is present at every level (sleep window generation, minimum time-in-bed, sleep efficiency titration criteria, and positioning of sleep window). Only 7% of papers reported all parameters of sleep restriction treatment. Poor reporting and variability in the application of sleep restriction therapy may hinder progress in relation to evidence synthesis, specification of mechanistic components, and refinement of therapeutic procedures for patient benefit. We set out guidelines for the reporting of sleep restriction therapy as well as a research agenda aimed at advancing understanding of sleep restriction therapy.
A double-blind randomised controlled study of a brief intervention of bedtime restriction for adult patients with primary insomnia. [2015]Bedtime restriction is effective for volunteer patients with primary insomnia.
Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization. [2022]Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes.
Treatment of chronic insomnia by restriction of time in bed. [2022]A treatment of chronic insomnia is described that is based on the recognition that excessive time spent in bed is one of the important factors that perpetuates insomnia. Thirty-five patients, with a mean age of 46 years and a mean history of insomnia of 15.4 years, were treated initially by marked restriction of time available for sleep, followed by an extension of time in bed contingent upon improved sleep efficiency. At the end of the 8-week treatment program, patients reported an increase in total sleep time (p less than 0.05) as well as improvement in sleep latency, total wake time, sleep efficiency, and subjective assessment of their insomnia (all p less than 0.0001). Improvement remained significant for all sleep parameters at a mean of 36 weeks after treatment in 23 subjects participating in a follow-up assessment. Although compliance with the restricted schedule is difficult for some patients, sleep restriction therapy is an effective treatment for common forms of chronic insomnia.