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The Effect of Sleep Loss on Emotion Regulation

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ClinicalTrials.gov Identifier: NCT05393830
Recruitment Status : Not yet recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Janet M Mullington, PhD, Beth Israel Deaconess Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sleep Insomnia Sleep Deprivation Behavioral: Sleep Restriction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Independent Groups Comparison
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : July 31, 2027

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
Behavioral: Sleep Restriction
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



Primary Outcome Measures :
  1. Baseline Emotional Regulation Task with Strategy [ Time Frame: Day 1 ]
    Baseline behavioral ratings to emotional stimuli with emotion regulation strategies

  2. Baseline Emotional Regulation Task without Strategy [ Time Frame: Day 1 ]
    Baseline behavioral ratings to emotional stimuli without emotion regulation strategies

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: one test in a 3-6 day window ]
    fMRI measured neural reactivity (blood oxygen-level dependent signal)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393830


Contacts
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Contact: Tony J Cunningham, PhD 617-667-3337 acunnin4@BIDMC.Harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Janet M Mullington, PhD Beth Israel Deaconess Medical Center
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Responsible Party: Janet M Mullington, PhD, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05393830    
Other Study ID Numbers: 2022P000120
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are developing our institutional data sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janet M Mullington, PhD, Beth Israel Deaconess Medical Center:
Emotion
Sleep Restriction
Insomnia Disorder
Sleep
Emotion Regulation
functional Magnetic Resonance Imaging (fMRI)
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Deprivation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations