NCT03227406

Brief Summary

To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

6.9 years

First QC Date

July 19, 2017

Last Update Submit

February 1, 2023

Conditions

Sleep DeprivationSleep

Keywords

sleepmemoryREM sleepslow wave sleepcognitionsleep spindles

Outcome Measures

Primary Outcomes (4)

  • Motor sequence task improvement

    The increase in the number of correct sequences typed, from the last three training trials to the first three delayed-test trials, is calculated as a percent improvement.

    4-24 hrs

  • 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.

    4-24 hrs

  • Serial reaction time test improvement

    At two time points, separated by a period of wake or sleep, the average reaction time to stimuli in repeated sequence blocks is subtracted from the average reaction time in random blocks. The percent increase in this difference, from the final blocks in the first test to the first blocks in the second test, is calculated as a percent improvement.

    4-24 hrs

  • Visual discrimination task improvement

    At two time points, separated by a period of wake or sleep, the interpolated stimulus-mask ISI corresponding to 80% accuracy on the texture discrimination task is determined, and task improvement is calculated as the difference between these thresholds, in ms.

    4-24 hrs

Secondary Outcomes (4)

  • Sleep architecture (absolute times)

    4-24 hrs

  • Sleep architecture (percent times)

    4-24 hrs

  • Spindle

    4-24 hrs

  • Sleep microstructure

    4-24 hrs

Study Arms (4)

Daytime Wake

NO INTERVENTION

Subjects are trained and retested during a single period of daytime wake

Overnight sleep

NO INTERVENTION

Subjects are trained on one day and tested the next day, after a night of normal sleep

Sleep deprivation

EXPERIMENTAL

Subjects are trained on one day and tested the next day, after a night of sleep deprivation

Behavioral: Sleep deprivation

Daytime Nap

EXPERIMENTAL

Subjects are trained and then retested after a daytime nap

Behavioral: Nap

Interventions

Sleep deprivationBEHAVIORAL

Subjects are kept awake all night.

Sleep deprivation
NapBEHAVIORAL

Participants are given a 90-minute nap opportunity in the early afternoon.

Daytime Nap

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
  • in some cases, English as a first language, normal hearing, and/or normal or corrected to normal vision is required

You may not qualify if:

  • self-reported sleep disturbances
  • a history of mental illness
  • 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)

Robert Stickgold

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Stickgold, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 24, 2017

Study Start

March 1, 2016

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

US(1)