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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

Summary

This trial investigates if playing sounds during deep sleep can improve sleep and memory in people with early-course schizophrenia. The study aims to see if enhancing specific brain activities during sleep helps with cognitive functions.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily involve antipsychotic medications, which work by modulating neurotransmitter activity in the brain, particularly dopamine and serotonin. These medications help reduce symptoms such as hallucinations, delusions, and disorganized thinking. The study on auditory tones during deep sleep aims to enhance specific sleep features, potentially improving cognitive performance. This is significant for schizophrenia patients as cognitive deficits are a core feature of the disorder, and improving sleep quality may offer a novel approach to mitigating these cognitive impairments, complementing traditional pharmacological treatments.
Behavioral interventions for alleviating psychotic symptoms.Preferences for different insomnia treatment options in people with schizophrenia and related psychoses: a qualitative study.

Find a Location

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
2,869 Previous Clinical Trials
2,777,336 Total Patients Enrolled
253 Trials studying Schizophrenia
89,724 Patients Enrolled for Schizophrenia
Fabio Ferrarelli, MD,PhDPrincipal InvestigatorUniversity of Pittsbrugh

Media Library

Experimental: Night three- sham, night four - active Clinical Trial Eligibility Overview. Trial Name: NCT05956951 — N/A
Schizophrenia Research Study Groups: Experimental: Night three- sham, night four - active, Experimental: Night three - active, night four - sham
Schizophrenia Clinical Trial 2023: Experimental: Night three- sham, night four - active Highlights & Side Effects. Trial Name: NCT05956951 — N/A
Experimental: Night three- sham, night four - active 2023 Treatment Timeline for Medical Study. Trial Name: NCT05956951 — N/A
~133 spots leftby Jun 2028
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