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Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

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ClinicalTrials.gov Identifier: NCT04783571
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Placebo Other: Auditory Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Schizophrenia
Adult outpatients with a diagnosis of schizophrenia.
 Other: Placebo
Auditory stimulation will not be delivered during the nap

Other: Auditory Stimulation
Auditory stimulation will be delivered during the nap
Experimental: Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
 Other: Placebo
Auditory stimulation will not be delivered during the nap

Other: Auditory Stimulation
Auditory stimulation will be delivered during the nap


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Differences in sleep-dependent consolidation of motor procedural memory [ Time Frame: Placebo and auditory stimulation naps will be approximately one week apart ]
    Differences in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between placebo and auditory stimulation naps. The MST involves pressing four numerically labeled keys on a standard keypad, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences are employed for the placebo and stimulation visits in a counter-balanced order.

  2. Differences in slow oscillations [ Time Frame: Placebo and auditory stimulation naps will be approximately one week apart ]
    Differences in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps

  3. Differences in sleep spindles [ Time Frame: Placebo and auditory stimulation naps will be approximately one week apart ]
    Differences in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783571


Contacts
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Contact: Lindsey Woodham 617-726-0307 manoachlab@gmail.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dara Manoach, PhD    617-724-6148    manoachlab@gmail.com   
Principal Investigator: Dara Manoach, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Dara Manoach, PhD Massachusetts General Hospital
More Information
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Responsible Party: Dara S. Manoach, PhD, Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04783571    
Other Study ID Numbers: 2018P002573
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dara S. Manoach, PhD, Massachusetts General Hospital:
sleep
memory
schizophrenia
auditory stimulation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders