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

Schizophrenia Clinical Trial

Official title:

The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386588
• Other study ID #: 2024P000610
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Lindsey Jones, MS
• Phone: 617-702-2368
• Email: manoachlab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Closed loop auditory stimulation during sleep
Short bursts of pink noise delivered at precise times during overnight sleep at home.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sleep physiology	Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband	across 5 nights of sleep with auditory stimulation
Primary	Changes in functional connectivity of the hippocampus and thalamus	Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI	Approximately 1 week between baseline and follow-up scans
Primary	Changes in hippocampal activation during motor sequence task (MST)	Changes in hippocampal activation during the MST as measured by functional MRI	Approximately 1 week between baseline and follow-up scans
Primary	Changes in hippocampal microstructural integrity	Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI	Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Secondary	Greater gains in typing speed over rest breaks during MST training (micro-offline gains)	MST training sessions prior to sleep consisting of typing trials separated by rest periods. We will measure typing speed before and after rest breaks.	Approximately 5 days between pre- and post-stimulation MST administrations
Secondary	Sleep dependent memory consolidation (SDMC)	Comparison of SDMC between the Baseline MST only and MST with CLASS nights	Approximately 5 days between pre- and post-stimulation MST administrations