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 — OTHER
    Short 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: 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.

Primary Outcome Measure

Changes in sleep physiology [ Time Frame: across 5 nights of sleep with auditory stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02129
Dara Manoach, PhD
617-724-6148
Lindsey Jones, MS
617-702-2368
Dara Manoach, PhD (PRINCIPAL_INVESTIGATOR)

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