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Sleep Restriction for Insomnia

N/A
Recruiting
Led By Janet M Mullington, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal or corrected to normal vision is required
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one test in a 3-6 day window
Awards & highlights

Study Summary

This trial investigates how lack of sleep affects emotional processing and regulation compared to those with Insomnia Disorder. It will address how distinct neural mechanisms are involved. The findings could help understand the role of sleep in emotional functioning.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves sleep restriction, participants may experience increased tiredness, mood changes, difficulty concentrating, irritability, and potential stress due to altered sleeping patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My vision is normal or corrected to normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one test in a 3-6 day window
This trial's timeline: 3 weeks for screening, Varies for treatment, and one test in a 3-6 day window for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline Emotional Regulation Task with Strategy
Baseline Emotional Regulation Task without Strategy
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
+1 more
Secondary outcome measures
Functional Magnetic Resonance Imaging (fMRI)

Trial Design

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 Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,182 Total Patients Enrolled
6 Trials studying Sleep Deprivation
4,404 Patients Enrolled for Sleep Deprivation
Janet M Mullington, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
270 Total Patients Enrolled

Media Library

Sleep Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05393830 — N/A
Sleep Deprivation Research Study Groups: Patients with Insomnia Disorder, Normal Sleep, Sleep Restriction
Sleep Deprivation Clinical Trial 2023: Sleep Restriction Highlights & Side Effects. Trial Name: NCT05393830 — N/A
Sleep Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393830 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots to take part in this clinical investigation?

"According to information hosted on clinicaltrials.gov, this study is still accepting participants. The trial was first made available for recruitment on the 11th of May 2023 and has seen its last update as recently as July 25th 2023."

Answered by AI

Are applicants above the age of seventy-five excluded from participating in this trial?

"This trial specifically requires that participants are aged 18 or above and not more than 40 years old."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative, the information hosted on clinicaltrials.gov verifies that recruitment for this experiment is currently underway. It was initially listed on May 11th 2023 and its details were last modified on July 25th 2023; 90 participants need to be enrolled at a single site."

Answered by AI

Who are the eligible participants for this research initiative?

"A maximum of 90 slumbering individuals aged 18 - 40 are being admitted to this trial. Criteria for applicants include: fulfilment of the fMRI scanning criteria, abstention from alcohol and illicit drugs while participating in the study, unaided or corrected-to-normal vision, and the capacity to adhere strictly to protocol requirements."

Answered by AI

Who else is applying?

What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Effect of Sleep Loss on Emotion Regulation
Janet M Mullington, PhD 2023. "The Effect of Sleep Loss on Emotion Regulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05393830.
All > Sleep Disorders
~60 spots leftby Jan 2027
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