NCT05956951 · Fabio Ferrarelli
Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation
(RESPITE)
What this 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.
View original scientific description
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.
Interventions
DEVICE
Closed-loop auditory stimulation
Closed-loop auditory stimulation will be administered by a wearable EEG device (Philips SmartSleep Deep Sleep Headband). The EEG device will deliver auditory stimulation when slow-wave (deep) sleep is detected. Auditory stimulation will consist of 50ms long tones separated from each other by a fixed one-second inter-tone interval. The volume of each tone will be linearly modulated by sleep-depth such that louder (or softer) tones were played during deeper (or shallower) sleep.
DEVICE
Sham auditory stimulation
Sham auditory stimulation consists of closed-loop auditory stimulation not being administered. A wearable EEG device (Philips SmartSleep Deep Sleep Headband) will not deliver closed-loop auditory stimulation and tones will not be played.
Primary outcome measures
Deficits in sleep spindle and slow wave density in early-course schizophrenia patients (EC-SCZ).
Time frame: baseline (pre closed-loop auditory stimulation)
The difference between sleep spindle and slow wave density (measured as count per minute) in EC-SCZ relative to HC as recorded on a wireless ambulatory monitor.
Deficits in sleep spindle and slow wave duration in early-course schizophrenia patients (EC-SCZ).
Time frame: baseline (pre closed-loop auditory stimulation)
The difference between sleep spindle and slow wave duration (measured in seconds) in EC-SCZ relative to HC as recorded on a wireless ambulatory monitor.
Deficits in sleep spindle and slow wave amplitude in early-course schizophrenia patients (EC-SCZ).
Time frame: baseline (pre closed-loop auditory stimulation)
The difference between sleep spindle and slow wave amplitude (measured in microvolts) in EC-SCZ relative to HC as recorded on a wireless ambulatory monitor.
Improvement in sleep spindle and slow wave density.
Time frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Changes in sleep spindle and slow wave density (measured as count per minute) in EC-SCZ patients before and after closed-loop auditory stimulation during sleep.
Improvement in sleep spindle and slow wave duration.
Time frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Changes in sleep spindle and slow wave duration (measured in seconds) in EC-SCZ patients before and after closed-loop auditory stimulation during sleep.
Improvement in sleep spindle and slow wave amplitude.
Time frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Changes in sleep spindle and slow wave amplitude (measured in microvolts) in EC-SCZ patients before and after closed-loop auditory stimulation during sleep.
Relationship between spindle and slow wave deficits and memory consolidation.
Time frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Changes in task-assessed memory consolidation scores before and after closed-loop auditory stimulation in EC-SCZ compared to controls. Percent change in number of correct sequences in the morning compared to previous night on the Motor Sequence Tapping (MST) task will provide a proxy measure of overnight memory consolidation. Higher scores on the MST represent better performance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations