- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05393830
The Effect of Sleep Loss on Emotion Regulation
The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Goal 1: How does sleep loss and clinical sleep disruption (i.e. Insomnia Disorder) impact emotion perception and emotion regulation? The investigators are interested in how chronic loss of sleep, either through artificially restricting sleep or clinically related sleep disturbance, impairs our ability to properly perceive and regulate our responses to emotional information using various emotion regulation strategies. There has been research on the effect of sleep loss on broad areas of cognition, such as attention, working memory, and reasoning ability, but the impact of long-term sleep loss on emotional processing and regulation remains largely unexplored. The investigators aim to characterize how sleep loss via experimentally reduced sleep in healthy control participants or clinical sleep disturbance in patients with Insomnia Disorder, affects the ability to accurately perceive emotion. Investigators will also investigate how it alters the intensity with which emotions are perceived, and the effect that these changes have on the ability to regulate emotional responses to these stimuli compared to healthy control participants that are allowed undisturbed sleep.
Goal 2: How are changes in subjective emotional responses reflected in the neural signal and psychophysiological measures? The investigators will utilize fMRI and measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural and psychophysiological responses that are associated with behavioral changes following sleep restriction or in patients with Insomnia disorder compared to healthy sleep control participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tony J Cunningham, PhD
- Phone Number: 617-667-3337
- Email: acunnin4@BIDMC.Harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
-
Contact:
- Tony Cunningham, PhD
- Phone Number: 617-667-4702
- Email: acunnin4@bidmc.harvard.edu
-
Contact:
- Janet Mullington, PhD
- Phone Number: 617-667-0434
- Email: jmulling@BIDMC.Harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- willing and able to follow the protocol
- willing and able to meet inclusion criteria for fMRI scanning
- willing to refrain from alcohol and recreational drugs for the duration of the protocol
- normal or corrected to normal vision is required
Exclusion Criteria:
- left-handedness or ambidexterity
- the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Normal Sleep
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
|
|
Active Comparator: Sleep Restriction
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
|
Three nights of sleep restricted to 4 hours per night.
|
No Intervention: Patients with Insomnia Disorder
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Emotional Regulation Task with Strategy
Time Frame: Day 1
|
Baseline behavioral ratings to emotional stimuli with emotion regulation strategies
|
Day 1
|
Baseline Emotional Regulation Task without Strategy
Time Frame: Day 1
|
Baseline behavioral ratings to emotional stimuli without emotion regulation strategies
|
Day 1
|
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Time Frame: one test in a 3-6 day window
|
Behavioral ratings to emotional stimuli with emotion regulation strategies following normal sleep or sleep restriction
|
one test in a 3-6 day window
|
Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Time Frame: one test in a 3-6 day window
|
Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction
|
one test in a 3-6 day window
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Magnetic Resonance Imaging (fMRI)
Time Frame: one test in a 3-6 day window
|
fMRI measured neural reactivity (blood oxygen-level dependent signal)
|
one test in a 3-6 day window
|
Collaborators and Investigators
Investigators
- Principal Investigator: Janet M Mullington, PhD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022P000120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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