NCT03840083

Brief Summary

The specific objective of this proposed research is to understand whether deficits in sleep-dependent memory changes reflect age-related changes in sleep, memory, or both. The central hypothesis is that changes in both memory and sleep contribute to age-related changes in sleep-dependent memory processing. To this end, the investigators will investigate changes in learning following intervals of sleep (overnight and nap) and wake in young and older adults.

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
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

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 Start

First participant enrolled

July 15, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

February 4, 2019

Last Update Submit

March 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in memory accuracy for intervention compared to control

    We will measure memory accuracy before the sleep/wake interval and subtract this from memory accuracy after the sleep wake interval. If sleep benefits memory then this value will be greater in the sleep condition compared to the wake condition.

    2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)

Study Arms (2)

Sleep

EXPERIMENTAL

Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)

Behavioral: Sleep

Wake

NO INTERVENTION

Individuals will stay awake for the same amount of time as they slept in the sleep condition

Interventions

SleepBEHAVIORAL

Participants will sleep (either a mid-day nap or normal overnight sleep)

Sleep

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 yrs
  • Healthy sleeper
  • No diagnosed sleep or neurodegenerative disorder

You may not qualify if:

  • Past diagnosis neurological illness or head injury
  • Reported average sleep per night \< 5 or \> 9 hrs
  • Current employment involving shift work or an inability to keep a regular sleep schedule during the week prior to testing
  • Current use of psychotropic, recreational drugs, or sleep-altering medications (sleep medications, cold medicines within the past week, clonidine, sympathomimetic stimulants)
  • Daily caffeine intake of \> 4 cups (coffee, tea, colas)
  • Weekly alcohol intake of \> 10 cups
  • Pregnancy or \< 12 months post-partum
  • History of bipolar disorder, mania, or current evidence of depression as measured by Beck Depression Inventory score \> 25
  • Abnormal sleep (e.g., shift work, travel across \>2 time zones within the past 3 months).
  • Diagnosis of any Axis I disorder, neurological illness or head injury (according to Demographic and Health History form);
  • Score indicative of cognitive dysfunction (subtest scores \< 40)
  • Beck Depression Scale score indicative of depression (\> 19).
  • Additionally, individuals will be excluded from magnetic resonance imaging studies (Exps 1, 4) for:
  • Left handed or ambidextrous
  • Claustrophobia
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

RECRUITING

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 15, 2019

Study Start

July 15, 2018

Primary Completion

July 14, 2025

Study Completion

July 15, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations