NCT05393830

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
May 2023Jul 2027

First Submitted

Initial submission to the registry

May 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

May 11, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

May 20, 2022

Last Update Submit

April 9, 2026

Conditions

Keywords

EmotionSleep RestrictionInsomnia DisorderSleepEmotion Regulationfunctional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (4)

  • Baseline Emotional Regulation Task with Strategy

    Baseline behavioral ratings to emotional stimuli with emotion regulation strategies

    Day 1

  • Baseline Emotional Regulation Task without Strategy

    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

    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

    Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction

    one test in a 3-6 day window

Secondary Outcomes (1)

  • Functional Magnetic Resonance Imaging (fMRI)

    one test in a 3-6 day window

Study Arms (3)

Normal Sleep

NO 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

Sleep Restriction

ACTIVE COMPARATOR

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

Patients with Insomnia Disorder

NO 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

Interventions

Three nights of sleep restricted to 4 hours per night.

Sleep Restriction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • willing and able to follow the protocol
  • willing to refrain from alcohol and recreational drugs for the duration of the protocol
  • normal or corrected to normal vision is required

You may not qualify if:

  • left-handedness or ambidexterity
  • the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep DeprivationEmotional Regulation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • Janet M Mullington, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony J Cunningham, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Independent Groups Comparison
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology in the Department of Psychiatry

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 26, 2022

Study Start

May 11, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

We are developing our institutional data sharing plan

Locations