The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
Part of paid clinical trials in Charlestown, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT06386588
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Closed loop auditory stimulation during sleep — OTHERShort bursts of pink noise delivered at precise times during overnight sleep at home.
Study Details
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.
Key Dates
- Start date
- Feb 5, 2025
- Status verified
- May 2025
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: SchizophreniaAdult outpatients with a diagnosis of schizophrenia.
- Active Comparator: Healthy ControlsAdult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
Primary Outcome Measure
Changes in sleep physiology [ Time Frame: across 5 nights of sleep with auditory stimulation ]
Central Contacts
- Lindsey Jones, MS617-702-2368
- Dara Manoach, PhD617-724-6148
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | Dara Manoach, PhD (PRINCIPAL_INVESTIGATOR) |
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