Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05393830

Conditions

Sleep

Insomnia

Sleep Deprivation

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Sleep Restriction

Study Details

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.

Conditions

Sleep

Insomnia

Sleep Deprivation

Study ID

NCT05393830

Start date

May 11, 2023

Status verified date

Apr, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

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

Interventions

Sleep Restriction

Three nights of sleep restricted to 4 hours per night.

Primary outcome measure

  • Baseline Emotional Regulation Task with Strategy [ Time Frame: Day 1 ]
  • Baseline Emotional Regulation Task without Strategy [ Time Frame: 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Tony J Cunningham, PhD

617-667-3337acunnin4@BIDMC.Harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Tony Cunningham, PhD

617-667-4702acunnin4@bidmc.harvard.edu

Janet Mullington, PhD

617-667-0434jmulling@BIDMC.Harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Emotion
  • Sleep Restriction
  • Insomnia Disorder
  • Sleep
  • Emotion Regulation
  • functional Magnetic Resonance Imaging (fMRI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.