NCT06688526

Brief Summary

The investigators are testing the impact of quiet sounds played during sleep on brain oscillations and memory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

October 25, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

November 13, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

October 25, 2024

Last Update Submit

April 26, 2026

Conditions

Healthy Control

Outcome Measures

Primary Outcomes (1)

  • Sleep spindle rate

    Sleep spindles are prominent thalamocortical brain oscillations seen on EEG during sleep that have been mechanistically linked to sleep-dependent memory consolidation. The sleep spindle rate over the course of the nap will be assessed using an automated spindle detector applied to the collected EEG sleep data.

    90 minutes

Secondary Outcomes (1)

  • Memory consolidation

    90 minutes

Study Arms (2)

Auditory Stimulation

ACTIVE COMPARATOR

Quiet sounds are played during sleep

Other: Quiet Sounds

Sham Stimulation

SHAM COMPARATOR

Volume is set to zero.

Other: Sham sounds

Interventions

Quiet SoundsOTHER

Quiet sounds are played during sleep

Auditory Stimulation
Sham soundsOTHER

No sounds are played during sleep

Sham Stimulation

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athinoula A. Martinos Center Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

Study Officials

  • Catherine Chu, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Neurology

Study Record Dates

First Submitted

October 25, 2024

First Posted

November 14, 2024

Study Start

November 13, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared upon request to the study PI

Time Frame
within one year of study termination
Access Criteria
Academic investigators

Locations

US(1)