Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

NCT04783571 | Active Not Recruiting

• 1 other identifier: 2018P002573
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

sleep; memory; schizophrenia; auditory stimulation

Outcome Measures

Primary Outcomes (1)

• Differences in slow-oscillation spindle coupling

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

  Placebo and auditory stimulation naps will be approximately one week apart

Secondary Outcomes (3)

• Differences in sleep-dependent consolidation of motor procedural memory

  Placebo and auditory stimulation naps will be approximately one week apart

• 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

Study Arms (2)

Schizophrenia

EXPERIMENTAL

Adult outpatients with a diagnosis of schizophrenia.

Other: Placebo; Other: Auditory Stimulation

Healthy Controls

EXPERIMENTAL

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

Other: Placebo; Other: Auditory Stimulation

Interventions

Placebo OTHER

Auditory stimulation will not be delivered during the nap

Healthy Controls; Schizophrenia

Auditory Stimulation OTHER

Auditory stimulation will be delivered during the nap

Healthy Controls; Schizophrenia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Any unstable chronic medical condition that affects sleep
• Diagnosed sleep disorder

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Dara Manoach, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 5, 2021
• Study Start: April 13, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)