NCT03767426

Brief Summary

To further understand the impact of acute sleep deprivation and recovery sleep on the processing of emotional information the investigators will address and attempt to answer three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms are associated with these behavioral effects, and (iii) to explore the ability of recovery sleep to reverse the effects of sleep deprivation. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in emotion processing and regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to lengthen work days and increase social opportunities- such knowledge would be of practical importance for understanding the role of sleep in healthy emotional functioning, particular for individuals experiencing periods of increased stress and emotional distress (e.g., new parents, hospital staff, or combat troops).

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

6.8 years

First QC Date

December 5, 2018

Last Update Submit

August 5, 2024

Conditions

Keywords

EmotionMemorySleepSleep Deprivation

Outcome Measures

Primary Outcomes (3)

  • Morphed Face Accuracy and Intensity

    Participants are asked to identify and rate emotional intensity of ambiguous emotional faces (happy, sad, angry) that have been morphed with neutral faces. Scores for each emotional domain will be calculated as (i) accuracy score (number of faces correctly identified over total faces seen), and (ii) average emotional intensity rating. Task will be completed at baseline, post-sleep/sleep deprivation, and post-nap/no nap, and within-subject comparisons will determine how interventions impact emotional perception.

    1-24 hours

  • Emotional Memory Tradeoff Memory Score

    Following sleep or sleep deprivation, participants will complete emotional memory tradeoff recognition task at two time points, separated by a nap or wakefulness. Corrected hit rate will be calculated for negative and neutral scene components as the percentage of correctly identified "old" objects/backgrounds minus percentage of false alarms ("new" pictures marked as "old")

    12-24 hours

  • Psychomotor vigilance task lapse rate

    The absolute number of trials in a 5-min test period on which the participant fails to responds with 500ms is calculated as the lapse rate.

    1-24 hours

Secondary Outcomes (3)

  • fMRI measured neural reactivity (blood oxygen-level dependent signal)

    12-24 hours

  • Heart Rate Reactivity (Beats per minute)

    12-24 hours

  • Skin Conductance Reactivity (micro Siemens)

    12-24 hours

Study Arms (3)

Overnight sleep

NO INTERVENTION

Subjects are permitted a night of polysomnograph-recorded sleep before participating in training and testing sessions the next day

Sleep deprivation

ACTIVE COMPARATOR

Subjects sleep deprived before participating in training and testing sessions the next day

Behavioral: Sleep Deprivation

Daytime Nap

EXPERIMENTAL

Subjects are trained and then retested after a daytime nap

Behavioral: Sleep DeprivationBehavioral: Daytime nap

Interventions

Subjects are sleep deprived for an entire night

Daytime NapSleep deprivation
Daytime napBEHAVIORAL

After a night of sleep deprivation, participants will be given a 2 hour nap opportunity

Daytime Nap

Eligibility Criteria

Age18 Years - 35 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:

  • self-reported sleep disturbances
  • left-handedness or ambidexterity
  • a history of mental illness or neurological disorder
  • the use of any drugs that could affect either sleep or cognitive functioning (e.g., sleeping pills or antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tony Cunningham

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Tony Cunningham, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony J Cunningham, PhD

CONTACT

Robert Stickgold, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Independent group comparison
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

March 1, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations