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Brain-Boosting sounds during sleep tested for schizophrenia

NCT ID NCT05956951

Knowledge-focused Sponsor: Fabio Ferrarelli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at brain activity during sleep in people with early-course schizophrenia compared to healthy individuals. Researchers will play soft tones during deep sleep using a wearable headband to see if it can strengthen sleep-related brain waves and improve memory. The goal is to understand sleep differences and explore a potential way to boost cognitive function without medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Closed-loop auditory stimulation via wearable EEG headband
What this could lead to
If successful, this could point toward a non-drug method to improve memory and thinking in people with early schizophrenia.
What could go wrong
This is an early-stage study focused on measuring brain activity, not a treatment trial. The sound stimulation may not produce meaningful cognitive benefits, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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