Recruiting

Auditory Stimulation

Sponsor:

Massachusetts General Hospital

Code:

NCT06386588

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Closed loop auditory stimulation during sleep

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT06386588

Start date

Feb 5, 2025

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Schizophrenia

Adult outpatients with a diagnosis of schizophrenia.

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.

Interventions

Closed loop auditory stimulation during sleep

Short bursts of pink noise delivered at precise times during overnight sleep at home.

Primary outcome measure

  • Changes in sleep physiology [ Time Frame: 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 hippocampal activation during motor sequence task (MST) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Lindsey Jones, MS

617-702-2368manoachlab@gmail.com

Dara Manoach, PhD

617-724-6148dara.manoach@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Dara Manoach, PhD

617-724-6148manoachlab@gmail.com

Lindsey Jones, MS

617-702-2368manoachlab@gmail.com

Principal Investigator:

Dara Manoach, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Hippocampus
  • Neuromodulation
  • Sleep spindles
  • Thalamocortical circuits
  • Auditory stimulation
  • Magnetic resonance imaging
  • Sleep
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.