The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia

May 13, 2025 updated by: Dara S. Manoach, PhD, Massachusetts General Hospital

The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia

In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Dara Manoach, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-45 years old
  • Fluent in English
  • Able to give informed consent

Additional inclusion for Adults with schizophrenia:

  • A DSM-V confirmed diagnosis of schizophrenia
  • Unmedicated or maintained on a stable dose of APDs

Exclusion Criteria:

  • Ferrous metal in the body
  • Currently pregnant or breastfeeding
  • Motor problems that preclude finger tapping task
  • IQ <85
  • Other neurological disorders, including seizure disorder
  • Significant hearing or vision loss
  • Chronic medical conditions that affect sleep
  • Unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
  • Diagnosed sleep disorder, except insomnia
  • History of head injury resulting in prolonged loss of consciousness or other neurological sequelae

Additional Exclusion Criteria for Healthy adults:

  • History of mental illness
  • Current use of psychotropic medications or treatment with medications known to affect sleep or cognition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Schizophrenia
Adult outpatients with a diagnosis of schizophrenia.
Other: Closed loop auditory stimulation during sleep
Short bursts of pink noise delivered at precise times during overnight sleep at home.
Active Comparator: Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
Other: Closed loop auditory stimulation during sleep
Short bursts of pink noise delivered at precise times during overnight sleep at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sleep physiology
Time Frame: across 5 nights of sleep with auditory stimulation
Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband
across 5 nights of sleep with auditory stimulation
Changes in functional connectivity of the hippocampus and thalamus
Time Frame: Approximately 1 week between baseline and follow-up scans
Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI
Approximately 1 week between baseline and follow-up scans
Changes in hippocampal activation during motor sequence task (MST)
Time Frame: Approximately 1 week between baseline and follow-up scans
Changes in hippocampal activation during the MST as measured by functional MRI
Approximately 1 week between baseline and follow-up scans
Changes in hippocampal microstructural integrity
Time Frame: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI
Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)
Time Frame: Approximately 5 days between pre- and post-stimulation MST administrations
MST training sessions prior to sleep consisting of typing trials separated by rest periods. We will measure typing speed before and after rest breaks.
Approximately 5 days between pre- and post-stimulation MST administrations
Sleep dependent memory consolidation (SDMC)
Time Frame: Approximately 5 days between pre- and post-stimulation MST administrations
Comparison of SDMC between the Baseline MST only and MST with CLASS nights
Approximately 5 days between pre- and post-stimulation MST administrations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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