NCT06386588 · Massachusetts General Hospital
The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Charlestown, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2025 · Source of record for eligibility and locations