Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Placebo; Other: Auditory Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey Woodham; Phone Number: 617-726-0307; Email: manoachlab@gmail.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Dara Manoach, PhD; Phone Number: 617-724-6148; Email: manoachlab@gmail.com
      • Principal Investigator: Dara Manoach, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Placebo and auditory stimulation naps will be approximately one week apart
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	Placebo and auditory stimulation naps will be approximately one week apart
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	Placebo and auditory stimulation naps will be approximately one week apart

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Dara Manoach, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: memory; sleep; schizophrenia; auditory stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2018P002573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No