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

Mass General Brigham

Status: Enrolling

Conditions: Schizophrenia

Treatments: Other: Closed loop auditory stimulation during sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT06386588

2024P000610

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Schizophrenia

Experimental group

Description:

Adult outpatients with a diagnosis of schizophrenia.

Treatment:

Other: Closed loop auditory stimulation during sleep

Healthy Controls

Active Comparator group

Description:

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

Treatment:

Other: Closed loop auditory stimulation during sleep