Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04783571
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 38.6
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Other: Placebo; Other: Auditory Stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 13, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Differences in slow-oscillation spindle coupling [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dara S. Manoach, PhD, Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04783571
• Other Study ID Numbers: 2018P002573
• First Posted: Mar 5, 2021
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Professor, Massachusetts General Hospital: sleep; memory; schizophrenia; auditory stimulation
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Aug 17, 2021