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Clinical Trials/NCT04783571
NCT04783571
Active, Not Recruiting
N/A

Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

Massachusetts General Hospital1 site in 1 country70 target enrollmentApril 13, 2020
ConditionsSchizophrenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Massachusetts General Hospital
Enrollment
70
Locations
1
Primary Endpoint
Differences in slow-oscillation spindle coupling
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.

Registry
clinicaltrials.gov
Start Date
April 13, 2020
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dara S. Manoach, PhD

Professor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • For healthy controls:
  • Male and female subjects
  • 18-50 years of age
  • Proficient in English
  • For schizophrenia patients:
  • Male and female schizophrenia outpatients
  • 18-50 years of age
  • Proficient in English
  • Able to give informed consent

Exclusion Criteria

  • Pregnant females
  • Current use of psychotropic medications (healthy controls only)
  • A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
  • Neurological disorder (including seizure disorder)
  • Significant hearing or vision loss
  • Current substance abuse or dependence (nicotine abuse or dependence is not exclusionary)
  • Any unstable chronic medical condition that affects sleep
  • Diagnosed sleep disorder

Outcomes

Primary Outcomes

Differences in slow-oscillation spindle coupling

Time Frame: Placebo and auditory stimulation naps will be approximately one week apart

Differences in slow oscillation-spindle coupling during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps

Secondary Outcomes

  • Differences in slow oscillations(Placebo and auditory stimulation naps will be approximately one week apart)
  • Differences in sleep spindles(Placebo and auditory stimulation naps will be approximately one week apart)
  • Differences in sleep-dependent consolidation of motor procedural memory(Placebo and auditory stimulation naps will be approximately one week apart)

Study Sites (1)

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