RecruitingNot Applicable

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

United States200 participantsStarted 2023-07-20

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ages 18-40 years
. current DSM-IV defined diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, not drug-induced, with no previously reported psychotic episode
. duration of ≤5 years from beginning of psychosis, defined by report of symptoms and/or history of treatment according to clinical guidelines employed in our University of Pittsburgh Medical Center (UPMC) psychoses clinics in Pittsburgh
. lifetime exposure to antipsychotic medications ≤5 years
. ages 18-40 years
. no lifetime history of psychiatric disorders
. no first-degree family history of schizophrenia spectrum disorder or mood disorder with psychotic features.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Deficits in sleep spindle and slow wave density in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Deficits in sleep spindle and slow wave duration in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Deficits in sleep spindle and slow wave amplitude in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Improvement in sleep spindle and slow wave density.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

Improvement in sleep spindle and slow wave duration.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

Improvement in sleep spindle and slow wave amplitude.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

Trial details

NCT IDNCT05956951

SponsorFabio Ferrarelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Chloe A Huston, MA

412-246-6114 hustonca@upmc.edu

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ages 18-40 years
. current DSM-IV defined diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, not drug-induced, with no previously reported psychotic episode
. duration of ≤5 years from beginning of psychosis, defined by report of symptoms and/or history of treatment according to clinical guidelines employed in our University of Pittsburgh Medical Center (UPMC) psychoses clinics in Pittsburgh
. lifetime exposure to antipsychotic medications ≤5 years
. ages 18-40 years
. no lifetime history of psychiatric disorders
. no first-degree family history of schizophrenia spectrum disorder or mood disorder with psychotic features.

What they're measuring

Deficits in sleep spindle and slow wave density in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Deficits in sleep spindle and slow wave duration in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Deficits in sleep spindle and slow wave amplitude in early-course schizophrenia patients (EC-SCZ).

Timeframe: baseline (pre closed-loop auditory stimulation)

Improvement in sleep spindle and slow wave density.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

Improvement in sleep spindle and slow wave duration.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

Improvement in sleep spindle and slow wave amplitude.

Timeframe: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria