Recruiting

Brain Activity

Sponsor:

Fabio Ferrarelli

Code:

NCT05956951

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Closed-loop auditory stimulation

Sham auditory stimulation

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT05956951

Start date

Jul 20, 2023

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental: Night three- sham, night four - active

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

experimental: Experimental: Night three - active, night four - sham

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

Interventions

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.

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 measure

  • Deficits in sleep spindle and slow wave density in early-course schizophrenia patients (EC-SCZ). [ Time Frame: baseline (pre closed-loop auditory stimulation) ]
  • Deficits in sleep spindle and slow wave duration in early-course schizophrenia patients (EC-SCZ). [ Time Frame: baseline (pre closed-loop auditory stimulation) ]
  • Deficits in sleep spindle and slow wave amplitude in early-course schizophrenia patients (EC-SCZ). [ Time Frame: baseline (pre closed-loop auditory stimulation) ]
  • Improvement in sleep spindle and slow wave density. [ Time Frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks) ]
  • Improvement in sleep spindle and slow wave duration. [ Time Frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks) ]
  • Improvement in sleep spindle and slow wave amplitude. [ Time Frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks) ]
  • Relationship between spindle and slow wave deficits and memory consolidation. [ Time Frame: baseline (pre closed-loop auditory stimulation), study completion (up to 6 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Fabio Ferrarelli, MD, PhD

ferrarellif@upmc.edu

More Information

Sponsor

Fabio Ferrarelli

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fabio Ferrarelli on 2026-06-04.