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NCT Number: NCT06386588

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed loop auditory stimulation during sleep

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

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

    Time frame: Approximately 5 days between pre- and post-stimulation MST administrations

    MST training sessions prior to sleep consisting of typing trials separated by rest periods. We will measure typing speed before and after rest breaks.

  2. Sleep dependent memory consolidation (SDMC)

    Time frame: Approximately 5 days between pre- and post-stimulation MST administrations

    Comparison of SDMC between the Baseline MST only and MST with CLASS nights

Study contacts

Contact information is provided by the study sponsor or research team.

Dara Manoach, PhD

CONTACT

[email protected]

617-724-6148

Lindsey Jones, MS

CONTACT

[email protected]

617-702-2368

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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