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Clinical Trials/NCT06386588
NCT06386588
Recruiting
N/A

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

Massachusetts General Hospital1 site in 1 country60 target enrollmentFebruary 5, 2025
ConditionsSchizophrenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Massachusetts General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Changes in functional connectivity of the hippocampus and thalamus
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2025
End Date
December 31, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dara S. Manoach, PhD

Professor

Massachusetts General Hospital

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
  • 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:

Outcomes

Primary Outcomes

Changes in functional connectivity of the hippocampus and thalamus

Time Frame: Approximately 1 week between baseline and follow-up scans

Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI

Changes in sleep physiology

Time Frame: across 5 nights of sleep with auditory stimulation

Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband

Changes in hippocampal microstructural integrity

Time Frame: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans

Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI

Changes in hippocampal activation during motor sequence task (MST)

Time Frame: Approximately 1 week between baseline and follow-up scans

Changes in hippocampal activation during the MST as measured by functional MRI

Secondary Outcomes

  • Sleep dependent memory consolidation (SDMC)(Approximately 5 days between pre- and post-stimulation MST administrations)
  • Greater gains in typing speed over rest breaks during MST training (micro-offline gains)(Approximately 5 days between pre- and post-stimulation MST administrations)

Study Sites (1)

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