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Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Auditory Stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring sleep, memory, schizophrenia, auditory stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Schizophrenia

Healthy Controls

Arm Description

Adult outpatients with a diagnosis of schizophrenia.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differences in sleep-dependent consolidation of motor procedural memory
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.
Differences in slow oscillations
Differences in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Differences in sleep spindles
Differences in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps

Full Information

First Posted
February 19, 2021
Last Updated
February 2, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04783571
Brief Title
Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Official Title
Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
sleep, memory, schizophrenia, auditory stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenia
Arm Type
Experimental
Arm Description
Adult outpatients with a diagnosis of schizophrenia.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Auditory stimulation will not be delivered during the nap
Intervention Type
Other
Intervention Name(s)
Auditory Stimulation
Intervention Description
Auditory stimulation will be delivered during the nap
Primary Outcome Measure Information:
Title
Differences in slow-oscillation spindle coupling
Description
Differences in slow oscillation-spindle coupling during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Time Frame
Placebo and auditory stimulation naps will be approximately one week apart
Secondary Outcome Measure Information:
Title
Differences in sleep-dependent consolidation of motor procedural memory
Description
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.
Time Frame
Placebo and auditory stimulation naps will be approximately one week apart
Title
Differences in slow oscillations
Description
Differences in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Time Frame
Placebo and auditory stimulation naps will be approximately one week apart
Title
Differences in sleep spindles
Description
Differences in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Time Frame
Placebo and auditory stimulation naps will be approximately one week apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Woodham
Phone
617-726-0307
Email
manoachlab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD
Phone
617-724-6148
Email
manoachlab@gmail.com
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD data.

Learn more about this trial

Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

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