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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 40 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares brain activity during sleep in healthy adults and adults with early schizophrenia or related disorders. It tests whether tones played during deep sleep can improve sleep features and whether those changes are linked to better thinking skills. It is for adults ages 18–40.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All participants must be ages 18–40.
- Patient group: Have schizophrenia, schizophreniform disorder, or schizoaffective disorder. These conditions can affect thinking and a person's sense of what is real.
- Patient group: The condition must not be caused by drugs, and no earlier episode of psychosis must have been reported. Psychosis means losing touch with reality.
- Patient group: Psychosis began no more than 5 years ago.
- Patient group: Have taken antipsychotic medicines for a total of no more than 5 years.
- Healthy group: Have never had a mental health disorder.
- Healthy group: No parent, sibling, or child has a schizophrenia-related disorder or a mood disorder with loss of touch with reality.
Who can't join
- Have an intellectual disability, which affects learning and everyday skills.
- Have a serious head injury, a major nervous system disorder such as seizures, or an illness that affects the brain.
- Are pregnant or less than 6 weeks past childbirth or miscarriage.
- Cannot understand the study and agree to take part.
- Have current or past dependence on alcohol or drugs that affect the mind.
- Have had substance abuse in the past year, other than cannabis or alcohol.
- Patient group: Have a psychotic illness linked in time to substance use or a head injury.
- Healthy group: Have trouble falling or staying asleep more than half the nights each week; have sleep apnea (breathing pauses during sleep) or restless legs syndrome (an urge to move the legs); or sleep less than 5 or more than 10 hours a day on average.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
PA
- University of Pittsburgh · Pittsburgh, PA 15213Fabio Ferrarelli, MD, PhD · Study contact · ferrarellif@upmc.eduMore trials in Pittsburgh