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Auditory Stimulation for Schizophrenia (RESPITE Trial)
N/A
Recruiting
Led By Fabio Ferrarelli, MD,PhD
Research Sponsored by Fabio Ferrarelli
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Awards & highlights
RESPITE Trial Summary
This trial will explore how sleep & brain activity differ between healthy people & those with schizophrenia & how tones during deep sleep can affect cognition.
Who is the study for?
This trial is for individuals aged 18-40 with early-course schizophrenia, schizophreniform, or schizoaffective disorder without a family history of similar conditions. They must have experienced psychosis for ≤5 years and had limited exposure to antipsychotic meds (≤5 years). Healthy controls without psychiatric disorders can also join. Exclusions include pregnancy, inability to consent, intellectual disabilities, significant neurological issues, certain sleep disorders, substance abuse (except cannabis/alcohol), and medical illnesses affecting the brain.Check my eligibility
What is being tested?
The study aims to compare brain activity during sleep between healthy individuals and those with schizophrenia-related diagnoses. It will test if playing tones during deep sleep can improve specific sleep features and cognitive performance in patients. Participants will receive either sham auditory stimulation or closed-loop auditory stimulation as part of the research.See study design
What are the potential side effects?
Since this trial involves non-invasive auditory stimulation rather than medication or surgery, side effects are expected to be minimal if any. However, participants may experience discomfort from wearing headphones during sleep or potential disruption in their normal sleep patterns.
RESPITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Deficits in sleep spindle and slow wave amplitude in early-course schizophrenia patients (EC-SCZ).
Deficits in sleep spindle and slow wave density in early-course schizophrenia patients (EC-SCZ).
Deficits in sleep spindle and slow wave duration in early-course schizophrenia patients (EC-SCZ).
+4 moreRESPITE Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental: Night three- sham, night four - activeExperimental Treatment2 Interventions
This arm will receive sham auditory stimulation for the first 3 nights and active auditory stimulation for the fourth night.
Night one - sham auditory stimulation, night 2 - sham auditory stimulation, night 3 - sham auditory stimulation, night 4 - active auditory stimulation
Group II: Experimental: Night three - active, night four - shamExperimental Treatment2 Interventions
This arm will receive sham auditory stimulation for the first two nights, active auditory stimulation for the third night, and sham auditory stimulation for the fourth night.
Night one - sham auditory stimulation, night two - sham auditory stimulation, night three - active auditory stimulation, night four - sham auditory stimulation
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Who is running the clinical trial?
Fabio FerrarelliLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Schizophrenia
75 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,499 Total Patients Enrolled
249 Trials studying Schizophrenia
89,235 Patients Enrolled for Schizophrenia
Fabio Ferrarelli, MD,PhDPrincipal InvestigatorUniversity of Pittsbrugh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia or a related disorder, without drug causes, and haven't had a psychotic episode before.My immediate family has no history of schizophrenia or mood disorders with psychosis.My condition is early-stage schizophrenia.I have a serious neurological condition.I have had a serious head injury.My condition is schizophrenia.I have a medical condition that affects my brain's function or structure.I have been diagnosed with sleep apnea or restless leg syndrome.I have used antipsychotic medications for 5 years or less.My psychosis started less than 5 years ago.I am between 18 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Night three- sham, night four - active
- Group 2: Experimental: Night three - active, night four - sham
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this investigational research available?
"To qualify for this trial, candidates must have schizophrenia and be between 18 and 40 years old. This medical research is currently seeking 200 participants in total."
Answered by AI
Is this research endeavor inclusive of people over 30 years old?
"As outlined in the eligibility criteria, this medical trial is for adults between 18 and 40 years old. For minors under 18 or elderly above 65 there are 44 trials and 188 trials respectively."
Answered by AI
What is the participant census for this investigation?
"Affirmative. Records on clinicaltrials.gov demonstrate that this medical trial is actively seeking subjects, with 200 patients needed to be enrolled from a single location. The study was first uploaded on July 1st 2023 and finalized edited on the 13th of the same month."
Answered by AI
Is this medical trial currently recruiting participants?
"Affirmative. Evidenced on clinicaltrials.gov, the recruitment of 200 participants from a single site is currently underway for this medical experiment which was first posted July 1st 2023 and updated two weeks later."
Answered by AI
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