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Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation

NCT05956951 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-05

No results posted yet for this study

Summary

The purpose of this research is to identify differences in brain activity during sleep between health individuals and individuals with schizophrenia, schizophreniform, or schizoaffective disorder. This study will also investigate whether tones played during deep sleep can enhance specific features of sleep and whether enhancing such features is related to an improvement in cognitive performance.

Conditions

Interventions

DEVICE

Closed-loop auditory stimulation

Closed-loop auditory stimulation will be administered by a wearable EEG device (Philips SmartSleep Deep Sleep Headband). The EEG device will deliver auditory stimulation when slow-wave (deep) sleep is detected. Auditory stimulation will consist of 50ms long tones separated from each other by a fixed one-second inter-tone interval. The volume of each tone will be linearly modulated by sleep-depth such that louder (or softer) tones were played during deeper (or shallower) sleep.

DEVICE

Sham auditory stimulation

Sham auditory stimulation consists of closed-loop auditory stimulation not being administered. A wearable EEG device (Philips SmartSleep Deep Sleep Headband) will not deliver closed-loop auditory stimulation and tones will not be played.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Fabio Ferrarelli

    lead OTHER

Principal Investigators

  • Fabio Ferrarelli, MD,PhD · University of Pittsbrugh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956951 on ClinicalTrials.gov