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

NCT ID: NCT06386588

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2027-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Schizophrenia

Adult outpatients with a diagnosis of schizophrenia.

Group Type: EXPERIMENTAL

Closed loop auditory stimulation during sleep

Intervention Type: OTHER

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

Healthy Controls

Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.

Group Type: ACTIVE_COMPARATOR

Closed loop auditory stimulation during sleep

Intervention Type: OTHER

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

Interventions

Closed loop auditory stimulation during sleep

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

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dara S. Manoach, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsey Jones, MS

Role: CONTACT

manoachlab@gmail.com

617-702-2368

Dara Manoach, PhD

Role: CONTACT

dara.manoach@mgh.harvard.edu

617-724-6148

Facility Contacts

Dara Manoach, PhD

Role: primary

manoachlab@gmail.com

617-724-6148

Lindsey Jones, MS

Role: backup

manoachlab@gmail.com

617-702-2368

Other Identifiers

2024P000610

Identifier Type: -

Identifier Source: org_study_id