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The Effect of Sleep Loss on Emotion Regulation

Primary Purpose

Sleep, Insomnia, Sleep Deprivation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Restriction
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep focused on measuring Emotion, Sleep Restriction, Insomnia Disorder, Sleep, Emotion Regulation, functional Magnetic Resonance Imaging (fMRI)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Normal Sleep

Sleep Restriction

Patients with Insomnia Disorder

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Baseline Emotional Regulation Task with Strategy
Baseline behavioral ratings to emotional stimuli with emotion regulation strategies
Baseline Emotional Regulation Task without Strategy
Baseline behavioral ratings to emotional stimuli without emotion regulation strategies
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Behavioral ratings to emotional stimuli with emotion regulation strategies following normal sleep or sleep restriction
Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction

Secondary Outcome Measures

Functional Magnetic Resonance Imaging (fMRI)
fMRI measured neural reactivity (blood oxygen-level dependent signal)

Full Information

First Posted
May 20, 2022
Last Updated
July 25, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05393830
Brief Title
The Effect of Sleep Loss on Emotion Regulation
Official Title
The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Insomnia, Sleep Deprivation
Keywords
Emotion, Sleep Restriction, Insomnia Disorder, Sleep, Emotion Regulation, functional Magnetic Resonance Imaging (fMRI)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Independent Groups Comparison
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Sleep
Arm Type
No Intervention
Arm Description
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
Arm Title
Sleep Restriction
Arm Type
Active Comparator
Arm Description
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
Arm Title
Patients with Insomnia Disorder
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sleep Restriction
Intervention Description
Three nights of sleep restricted to 4 hours per night.
Primary Outcome Measure Information:
Title
Baseline Emotional Regulation Task with Strategy
Description
Baseline behavioral ratings to emotional stimuli with emotion regulation strategies
Time Frame
Day 1
Title
Baseline Emotional Regulation Task without Strategy
Description
Baseline behavioral ratings to emotional stimuli without emotion regulation strategies
Time Frame
Day 1
Title
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Description
Behavioral ratings to emotional stimuli with emotion regulation strategies following normal sleep or sleep restriction
Time Frame
one test in a 3-6 day window
Title
Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Description
Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction
Time Frame
one test in a 3-6 day window
Secondary Outcome Measure Information:
Title
Functional Magnetic Resonance Imaging (fMRI)
Description
fMRI measured neural reactivity (blood oxygen-level dependent signal)
Time Frame
one test in a 3-6 day window

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony J Cunningham, PhD
Phone
617-667-3337
Email
acunnin4@BIDMC.Harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet M Mullington, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Cunningham, PhD
Phone
617-667-4702
Email
acunnin4@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Janet Mullington, PhD
Phone
617-667-0434
Email
jmulling@BIDMC.Harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are developing our institutional data sharing plan

Learn more about this trial

The Effect of Sleep Loss on Emotion Regulation

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