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

Fabio Ferrarelli · with National Institute of Mental Health (NIMH) · NCT05956951

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–40 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
1
Study start
July 20, 2023
Record last updated
June 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Closed-loop auditory stimulation; Sham auditory stimulation

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Early-course schizophrenia (EC-SCZ):

  • 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

Healthy controls (HC):

  • 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.

Exclusion Criteria

General exclusion criteria

  • DSM-IV intellectual disability
  • significant head injury
  • medical illness affecting brain function or structure
  • pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
  • significant neurological disorder (e.g. seizure disorder)
  • inability to provide informed consent
  • current or past co-morbidity for alcohol or psychoactive substance dependence
  • substance abuse other than cannabis and/or alcohol within the past one year

For EC-SCZ

a) a psychotic illness with a temporal relation to substance use or head injury

For healthy controls (HC):

  • difficult falling and/or staying asleep for more than half the nights of a week, on average
  • diagnosis of sleep apnea or restless leg syndrome
  • sleeping less than 5 hours or more than 10 hours daily, on average

Recruiting US locations

  • University of Pittsburgh

    Pittsburgh, PA 15213

    Site contact: Fabio Ferrarelli, MD, PhD · ferrarellif@upmc.edu

Study contacts (from the official record)

  • Chloe A Huston, MA · 412-246-6114 · hustonca@upmc.edu
All mental health studies in Pennsylvania →
Restoring Spindle and Thalamocortical Efficiency in Early-Course… (NCT05956951) | Bored Studies