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

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. ^{1 2 3 4 5}

How 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. ^{3 4 5 6 7}

Research Team

Janet M Mullington, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility 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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

The evidence base of sleep restriction therapy for treating insomnia disorder. [2022]

4. England 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. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

A double-blind randomised controlled study of a brief intervention of bedtime restriction for adult patients with primary insomnia. [2015]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic insomnia by restriction of time in bed. [2022]