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Behavioural Intervention

Auditory Stimulation During Sleep for Schizophrenia

N/A

Recruiting

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 minutes between pre- and post-task diffusion-weighted mri scans

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Greater gains in typing speed over rest breaks during MST training (micro-offline gains)

Sleep dependent memory consolidation (SDMC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met