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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06386588
Enrollment
60
Registered
2024-04-26
Start date
2025-02-05
Completion date
2027-12-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

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

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.

Interventions

OTHERClosed loop auditory stimulation during sleep

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in sleep physiologyacross 5 nights of sleep with auditory stimulationChanges in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband
Changes in functional connectivity of the hippocampus and thalamusApproximately 1 week between baseline and follow-up scansChanges in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI
Changes in hippocampal activation during motor sequence task (MST)Approximately 1 week between baseline and follow-up scansChanges in hippocampal activation during the MST as measured by functional MRI
Changes in hippocampal microstructural integrityApproximately 30 minutes between pre- and post-task diffusion-weighted MRI scansChanges in hippocampal microstructural integrity as measured by diffusion-weighted MRI

Secondary

MeasureTime frameDescription
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)Approximately 5 days between pre- and post-stimulation MST administrationsMST training sessions prior to sleep consisting of typing trials separated by rest periods. We will measure typing speed before and after rest breaks.
Sleep dependent memory consolidation (SDMC)Approximately 5 days between pre- and post-stimulation MST administrationsComparison of SDMC between the Baseline MST only and MST with CLASS nights

Countries

United States

Contacts

Primary ContactLindsey Jones, MS
manoachlab@gmail.com617-702-2368
Backup ContactDara Manoach, PhD
dara.manoach@mgh.harvard.edu617-724-6148

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026