Sleep Restriction for Insomnia

Overseen By Tony J Cunningham, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Sleeping pills, Antidepressants

Disqualifiers: Left-handedness, Ambidexterity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how limited sleep and insomnia affect emotions. Researchers will compare how people process and manage emotions when sleep-deprived or experiencing insomnia. Participants will either have normal sleep, be sleep-restricted to four hours for three nights, or have insomnia. Ideal candidates can follow the study rules, have normal vision, and do not use sleep or mood-altering drugs. The goal is to learn more about how sleep impacts emotional health. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on sleep and emotional health.

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.

What prior data suggests that sleep restriction is safe for participants?

Research has shown that insufficient sleep can lead to health changes. Sleeping only 4 hours a night for several nights may temporarily increase blood pressure and impair sugar processing. These changes typically normalize with adequate sleep. However, chronic sleep deprivation can result in more serious health issues, such as heart disease and diabetes.

Studies also suggest that insufficient sleep can affect emotions, making it harder to manage feelings when tired. Although these effects might seem concerning, participants generally find short-term sleep loss in this study manageable. It's important to consider personal health and consult a doctor before deciding to join a study like this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores sleep restriction as a potential technique for managing insomnia. Unlike traditional treatments like cognitive behavioral therapy or medication, which often focus on changing sleep habits or altering brain chemistry, sleep restriction involves limiting sleep to improve sleep quality and efficiency. This method could provide a drug-free alternative that might lead to quicker improvements in sleep patterns and has the potential to enhance emotion regulation, as observed through functional Magnetic Resonance Imaging (fMRI). If effective, this approach could offer a new, non-invasive option for those struggling with insomnia.

What evidence suggests that sleep restriction is effective for studying emotional processing and regulation in insomnia?

Research shows that getting only a few hours of sleep each night can greatly affect brain function and mood. Studies have found that sleeping just 3 to 6.5 hours can alter emotional regulation, leading to mood swings and changes in cognitive abilities. Insufficient sleep also links to health problems, including heart issues and mental well-being concerns. In this trial, one group of healthy participants will undergo sleep restriction, limited to 4 hours of sleep for 3 consecutive days, to understand its impact on emotional processing. Meanwhile, other participants will maintain normal sleep patterns for comparison. ^{2 3 6 7 8}

Who Is on the Research Team?

Janet M Mullington, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I am not taking any medication that affects my sleep or thinking.

You are left-handed or can use both hands equally.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Restriction

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with Insomnia Disorder Active Control 1 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 Sleep Active Control 1 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 Restriction Active Control 1 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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A systematic review of 88 trials on sleep restriction therapy for insomnia revealed that 39% of studies did not provide any details on the therapy's parameters, which may limit understanding and effectiveness.

Only 7% of the studies reported all relevant parameters of sleep restriction therapy, indicating significant variability in its application that could hinder the development of standardized treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards standardisation and improved understanding of sleep restriction therapy for insomnia disorder: A systematic examination of CBT-I trial content. Kyle, SD., Aquino, MR., Miller, CB., et al.[2018]

A randomized controlled trial involving 642 adults with insomnia showed that sleep restriction therapy significantly reduced insomnia severity compared to sleep hygiene alone, with a notable mean difference in insomnia severity index scores at 6 months.

The cost-effectiveness analysis indicated that sleep restriction therapy is likely to be cost-effective, with an incremental cost per quality-adjusted life year (QALY) gained of £2076, suggesting it could be a viable first-line treatment option for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial. Kyle, SD., Siriwardena, AN., Espie, CA., et al.[2023]

Sleep restriction therapy has been found to be an effective standalone treatment for chronic insomnia, showing moderate-to-large improvements in self-reported sleep measures such as sleep onset latency and sleep efficiency based on a review of nine relevant studies.

However, the studies reviewed were insufficient to fully assess the impact of sleep restriction therapy on objective sleep variables and daytime functioning, indicating a need for further research to clarify its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence base of sleep restriction therapy for treating insomnia disorder. Miller, CB., Espie, CA., Epstein, DR., et al.[2022]

In a study involving 52 adults with primary insomnia, bedtime restriction combined with basic sleep hygiene significantly improved sleep quality, with 73% of participants reporting better sleep compared to 35% in the control group.

The study suggests that bedtime restriction is an effective and feasible intervention for improving sleep quality in primary care settings, with a number needed to treat of 3, indicating that for every three patients treated, one will benefit significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomised controlled study of a brief intervention of bedtime restriction for adult patients with primary insomnia. Fernando, A., Arroll, B., Falloon, K.[2015]

A treatment for chronic insomnia involving sleep restriction was tested on 35 patients over 8 weeks, leading to significant improvements in total sleep time and other sleep parameters.

Improvements in sleep quality were maintained for at least 36 weeks after treatment, indicating that sleep restriction therapy is an effective long-term solution for chronic insomnia, despite some challenges in patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic insomnia by restriction of time in bed. Spielman, AJ., Saskin, P., Thorpy, MJ.[2022]

In a study involving 16 adults with Chronic Insomnia Disorder, sleep restriction therapy (SRT) over two weeks did not significantly affect daytime sleepiness or impairments in reaction time and driving performance, suggesting it may be a safe treatment option.

Participants successfully adhered to the SRT guidelines without a significant change in total sleep time, indicating that SRT can be implemented without risking major negative effects on daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daytime sleepiness, driving performance, reaction time and inhibitory control during sleep restriction therapy for Chronic Insomnia Disorder. Whittall, H., Pillion, M., Gradisar, M.[2019]

A study involving 56 participants with insomnia showed that sleep restriction therapy (SRT) significantly reduced insomnia severity compared to time in bed regularization (TBR), with a mean difference of -4.49 on the insomnia severity index after 4 weeks.

The results indicate that restricting time in bed is a crucial mechanism for improving sleep quality and continuity, as evidenced by both subjective reports and objective measurements, highlighting the effectiveness of SRT in treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Maurer, LF., Espie, CA., Omlin, X., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1978335/

Behavioral and Physiological Consequences of Sleep ... This paper reviews recent research on the effects of chronic sleep restriction on neurobehavioral and physiological functioning and discusses implications for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6473877/

The Global Problem of Insufficient Sleep and Its Serious ... Reduced sleep duration has been linked to 7 of the 15 leading causes of death in the U.S., including cardiovascular disease, malignant neoplasm, cerebrovascular ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424003981

A systematic and meta-analytic review of the impact ... We analysed 125 sleep restriction effect sizes from 39 reports involving 1234 participants. Restricting sleep (3–6.5 hours) compared to normal sleep (7–11 hours) ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.26918

Behavioral and Physiological Consequences of Sleep ... This paper reviews recent research on the effects of chronic sleep restriction on neurobehavioral and physiological functioning and discusses implications for ...

5. academic.oup.com academic.oup.com/sleep/article/48/8/zsaf135/8138369

The noninferiority complex: abrupt versus gradual restriction of ... Contemporary evidence suggests that sleep restriction therapy (SRT) may be the most effective single component cognitive-behavioral treatment ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK19961/

Extent and Health Consequences of Chronic Sleep Loss and ... Sleep loss and sleep disorders have been associated with a wide range of deleterious health consequences including an increased risk of hypertension, diabetes, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/B9780444537027000063

Total sleep deprivation, chronic sleep restriction and ... This review examines recent research on the effects of sleep deprivation, restriction and disruption on cognition and neurophysiologic functioning in healthy ...

8. academic.oup.com academic.oup.com/sleep/article/48/3/zsae275/7907787

Tired and out of control? Effects of total and partial sleep ... Sleep deprivation may impair top-down inhibitory control over emotional responses (e.g. under threat). The current study examined the behavioral ...