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

Not Applicable

Recruiting

• Conditions: Schizophrenia

• Registration Number: NCT06386588
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Study Start: 2025-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in functional connectivity of the hippocampus and thalamus	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
Changes in sleep physiology	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
Changes in hippocampal microstructural integrity	Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans	Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI
Changes in hippocampal activation during motor sequence task (MST)	Approximately 1 week between baseline and follow-up scans	Changes in hippocampal activation during the MST as measured by functional MRI

Secondary Outcome Measures

Name	Time	Method
Sleep dependent memory consolidation (SDMC)	Approximately 5 days between pre- and post-stimulation MST administrations	Comparison of SDMC between the Baseline MST only and MST with CLASS nights
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States