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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
No Placebo-Only Group
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.
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.
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 belowSelect...
My vision is normal or corrected to normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one test in a 3-6 day window
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one test in a 3-6 day window
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Functional Magnetic Resonance Imaging (fMRI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
853 Previous Clinical Trials
12,930,831 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medication that affects my sleep or thinking.My vision is normal or corrected to normal.You are left-handed or can use both hands equally.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Insomnia Disorder
- Group 2: Normal Sleep
- Group 3: Sleep Restriction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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