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Behavioural Intervention

Auditory Stimulation During Sleep for Schizophrenia

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-45 years old
Be between 18 and 65 years old
Must not have
Motor problems that preclude finger tapping task
History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 30 minutes between pre- and post-task diffusion-weighted mri scans
Awards & highlights

Summary

This trial will use sleep headbands to see if playing soft sounds during sleep can help improve brain coordination, network communication, and memory. They will study 30 adults with schizophrenia and 30 healthy adults

Who is the study for?
This trial is for adults aged 18-45 who have been diagnosed with schizophrenia. Participants will use a sleep headband at home to test if auditory stimulation during sleep can improve brain coordination and memory. They must be able to undergo MRI scans and perform a motor sequence task.
What is being tested?
The study tests whether soft sounds played through a sleep headband during specific times in the night can enhance brain network communication in individuals with schizophrenia, potentially leading to improved memory.
What are the potential side effects?
Since this trial involves non-invasive auditory stimulation and wearing a headband during sleep, side effects may include discomfort from wearing the device or disturbances in sleep patterns due to the sounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot perform tasks that require tapping my fingers due to motor issues.
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I have had a head injury that caused me to lose consciousness for a long time.
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I have a sleep disorder that is not insomnia.
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I am not currently taking any medications that affect my mood, sleep, or thinking.
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I have a neurological condition or seizures.
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I have significant hearing or vision loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 30 minutes between pre- and post-task diffusion-weighted mri scans
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 minutes between pre- and post-task diffusion-weighted mri scans for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in functional connectivity of the hippocampus and thalamus
Changes in hippocampal activation during motor sequence task (MST)
Changes in hippocampal microstructural integrity
+1 more
Secondary outcome measures
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)
Sleep dependent memory consolidation (SDMC)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SchizophreniaExperimental Treatment1 Intervention
Adult outpatients with a diagnosis of schizophrenia.
Group II: Healthy ControlsActive Control1 Intervention
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,618 Total Patients Enrolled
45 Trials studying Schizophrenia
6,946 Patients Enrolled for Schizophrenia
~40 spots leftby Jun 2027
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