Enhancing sleep quality in early schizophrenia patients using sound

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

This study is testing whether using sound during deep sleep can improve sleep quality and brain activity in people with early schizophrenia compared to healthy individuals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05956951 on ClinicalTrials.gov

What this trial studies

This research aims to explore differences in brain activity during sleep between healthy individuals and those with early-course schizophrenia. The study will utilize closed-loop auditory stimulation during deep sleep to enhance sleep spindle and slow wave activity, which may serve as biomarkers for schizophrenia. Participants will undergo multiple assessments, including sleep EEG recordings and cognitive performance tasks, to evaluate the effects of auditory stimulation on sleep quality and cognitive function. The study includes both early-course schizophrenia patients and healthy controls for comparative analysis.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-40 with a diagnosis of early-course schizophrenia, schizophreniform, or schizoaffective disorder.

Not a fit: Patients with significant head injuries, medical illnesses affecting brain function, or those with a history of intellectual disability may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve sleep quality and cognitive performance in patients with early schizophrenia.

How similar studies have performed: While this approach is innovative, similar studies exploring auditory stimulation during sleep have shown promise in enhancing sleep quality and cognitive function.

Eligibility criteria

Inclusion Criteria:

Early-course schizophrenia (EC-SCZ):

1. ages 18-40 years
2. current DSM-IV defined diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, not drug-induced, with no previously reported psychotic episode
3. 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
4. lifetime exposure to antipsychotic medications ≤5 years

Healthy controls (HC):

1. ages 18-40 years
2. no lifetime history of psychiatric disorders
3. no first-degree family history of schizophrenia spectrum disorder or mood disorder with psychotic features.

Exclusion Criteria:

General exclusion criteria:

1. DSM-IV intellectual disability
2. significant head injury
3. medical illness affecting brain function or structure
4. pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
5. significant neurological disorder (e.g. seizure disorder)
6. inability to provide informed consent
7. current or past co-morbidity for alcohol or psychoactive substance dependence
8. 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):

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

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Fabio Ferrarelli, MD,PhD — University of Pittsbrugh
• Study coordinator: Chloe A Huston, MA

Conditions Schizophrenia