What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications such as quetiapine, olanzapine, and risperidone. Known side effects of these medications can include somnolence, extrapyramidal symptoms, metabolic side effects like weight gain and diabetes, and increased mortality in older adults with dementia. Quetiapine, which has moderate D2 receptor antagonism, may cause fewer extrapyramidal side effects compared to other antipsychotics. Additionally, non-pharmacological interventions like metacognitive training and mindfulness therapy have shown promise in reducing symptoms with fewer side effects.

What prior FDA approvals exist?

FDA-approved treatments for schizophrenia primarily include antipsychotic medications, both first-generation (typical) and second-generation (atypical) antipsychotics. Atypical antipsychotics such as quetiapine and olanzapine have sedative properties that can help with sleep disturbances. While there are no specific FDA-approved treatments targeting sleep enhancement in schizophrenia, cognitive behavioral therapy for insomnia (CBT-I) is a non-pharmacological approach that has shown promise in improving sleep and cognitive function in various populations, including those with schizophrenia.

What other types of research exist?

Promising novel alternatives for enhancing sleep features and cognitive performance in schizophrenia patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving cognitive function and sleep quality. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which addresses sleep disturbances through behavioral changes and has been effective in various populations. 3) Bright Light Therapy, which can help regulate circadian rhythms and improve sleep quality. 4) Digital Therapeutics, such as mobile apps designed to improve sleep hygiene and cognitive function through personalized interventions.

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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

No Placebo-Only Group

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 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)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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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.