NCT05956951Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Jun 2023
- Start date
- 20 Jul 2023
- Primary completion date
- Jun 2028
- Lead sponsor
- Fabio Ferrarelli
- Diseases
- Schizophrenia
- NCT number
- NCT05956951
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 20 Jul 2023 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- medical illness affecting brain function or structure
- significant neurological disorder (e.g. seizure disorder)
- a psychotic illness with a temporal relation to substance use or head injury
- For healthy controls (HC):
- diagnosis of sleep apnea or restless leg syndrome
Other
- General exclusion criteria:
- DSM-IV intellectual disability
- significant head injury
- pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
- 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:
- difficult falling and/or staying asleep for more than half the nights of a week, on average
- sleeping less than 5 hours or more than 10 hours daily, on average
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.