RecruitingNot ApplicableNCT05956951

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

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


Sponsor

Fabio Ferrarelli

Enrollment

200 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is examining sleep brain wave patterns (specifically "sleep spindles") in people with early-course schizophrenia to better understand how the brain reorganizes itself during sleep and whether those patterns differ from healthy people. This is a research study, not a treatment trial. **You may be eligible if...** - You are 18 to 40 years old - You have a diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder for 5 years or less - You have been on antipsychotic medications for 5 years or less - OR you are a healthy volunteer with no personal or close family history of psychosis or mood disorders with psychosis **You may NOT be eligible if...** - You have an intellectual disability, significant brain injury, or seizure disorder - You are pregnant or recently postpartum (within 6 weeks) - You currently have or recently had alcohol or substance dependence - You are a healthy volunteer with regular sleep problems or a sleep disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClosed-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.

DEVICESham 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.


Locations(1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT05956951


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