What this study is
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.
What's being tested
- Closed loop auditory stimulation during sleep
Intervention · OTHER
Short bursts of pink noise delivered at precise times during overnight sleep at home.
Study details
- Official title
- The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
- Sponsor
- Massachusetts General Hospital
- Conditions
- Schizophrenia
- Enrolling
- 60 people
- Starts
- 2025-02-05
- Est. completion
- 2027-12-31
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 18-45 years old
- Fluent in English
- Able to give informed consent
- A DSM-V confirmed diagnosis of schizophrenia
- Unmedicated or maintained on a stable dose of APDs
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Charlestown, Massachusetts, United States
- Dara Manoach, PhD · Contact617-724-6148manoachlab@gmail.com
- Lindsey Jones, MS · Contact617-702-2368manoachlab@gmail.com
- Dara Manoach, PhD · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2024P000610
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.