Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT05956951

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

Led by Fabio Ferrarelli · Updated on 2025-06-05

200

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

Sponsors

F

Fabio Ferrarelli

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

C

Chloe A Huston, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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