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

NCT06386588 | Recruiting DMC

• 1 other identifier: 2024P000610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Hippocampus; Neuromodulation; Sleep spindles; Thalamocortical circuits; Auditory stimulation; Magnetic resonance imaging; Sleep; Memory

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Greater gains in typing speed over rest breaks during MST training (micro-offline gains)

  Approximately 5 days between pre- and post-stimulation MST administrations

• Sleep dependent memory consolidation (SDMC)

  Approximately 5 days between pre- and post-stimulation MST administrations

Study Arms (2)

Schizophrenia

EXPERIMENTAL

Adult outpatients with a diagnosis of schizophrenia.

Other: Closed loop auditory stimulation during sleep

Healthy Controls

ACTIVE COMPARATOR

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

Other: Closed loop auditory stimulation during sleep

Interventions

Closed loop auditory stimulation during sleep OTHER

Short bursts of pink noise delivered at precise times during overnight sleep at home.

Healthy Controls; Schizophrenia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Lindsey Jones, MS

CONTACT

617-702-2368; manoachlab@gmail.com

Dara Manoach, PhD

CONTACT

617-724-6148; dara.manoach@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 26, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)