Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783571
• Other study ID #: 2018P002573
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Lindsey Woodham
• Phone: 617-726-0307
• Email: manoachlab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Placebo
Auditory stimulation will not be delivered during the nap
• Auditory Stimulation
Auditory stimulation will be delivered during the nap

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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