The Effect of Sleep Loss on Emotion Regulation

NCT ID: NCT05393830

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Insomnia Sleep Deprivation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Independent Groups Comparison
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Sleep Restriction

Intervention Type BEHAVIORAL

Three nights of sleep restricted to 4 hours per night.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep Restriction

Three nights of sleep restricted to 4 hours per night.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Janet M Mullington, PhD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janet M Mullington, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tony J Cunningham, PhD

Role: CONTACT

617-667-3337

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tony Cunningham, PhD

Role: primary

617-667-4702

Janet Mullington, PhD

Role: backup

617-667-0434

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022P000120

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Deprivation Study
NCT05560620 COMPLETED NA
Sleep-dependent Learning in Aging
NCT03840083 RECRUITING NA
Sleep and Girls' Emotions Study
NCT04131868 COMPLETED NA
Sleep Health, Inflammation, and Emotion Study
NCT02270619 COMPLETED EARLY_PHASE1