Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

NCT ID: NCT04783571

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Schizophrenia

Adult outpatients with a diagnosis of schizophrenia.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Auditory stimulation will not be delivered during the nap

Auditory Stimulation

Intervention Type OTHER

Auditory stimulation will be delivered during the nap

Healthy Controls

Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Auditory stimulation will not be delivered during the nap

Auditory Stimulation

Intervention Type OTHER

Auditory stimulation will be delivered during the nap

Interventions

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Placebo

Auditory stimulation will not be delivered during the nap

Intervention Type OTHER

Auditory Stimulation

Auditory stimulation will be delivered during the nap

Intervention Type OTHER

Eligibility Criteria

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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
* IQ \<85
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dara S. Manoach, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dara Manoach, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018P002573

Identifier Type: -

Identifier Source: org_study_id

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