Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation
Fabio Ferrarelli · with National Institute of Mental Health (NIMH) · NCT05956951
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
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