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Smart Mattress Device for Epilepsy Prevention (Korus Trial)

N/A

Waitlist Available

Led By Jong Woo Lee, MD, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults age 18-65

Be older than 18 years old

Must not have

History of osteoporosis or osteopenia

Taking neuroactive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 seconds

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a smart mattress can accurately detect body position and reposition people from prone to recovery position. #smartmattress #feasibilitystudy

Who is the study for?

This trial is for healthy adults aged 18-65 who often sleep on their stomachs. It's not suitable for those with neurological, psychiatric, cardiac issues, bone diseases like osteoporosis, significant orthopedic problems, a history of falls or sleep disorders. People on certain medications or drugs and those with extreme body weights or blood pressure are also excluded.

What is being tested?

The Korus study tests a smart mattress designed to prevent SUDEP by detecting the user's sleeping position and automatically repositioning them from prone (face down) to sideways if necessary. Participants will simulate various sleeping positions to assess the device's accuracy and functionality.

What are the potential side effects?

Since this trial involves using a non-invasive device rather than medication, side effects are minimal but may include discomfort from being moved by the mattress or potential anxiety about using an automated system during sleep.

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 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with osteoporosis or osteopenia.

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I am taking medication that affects my brain function.

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I am currently taking blood thinners.

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I have a history of mental health issues, such as anxiety.

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I have a history of heart problems.

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I have a history of neurological issues or spinal cord problems.

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I have a history of sleep disorders.

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I have open wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 seconds

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 seconds

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 seconds for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Body position detection

Number of subjects correctly repositioned from the prone to recovery position

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Control subjectsExperimental Treatment1 Intervention

The subject will lie down on the Korus smart mattress. Korus will detect when the subject is in a prone (face-down) position and reposition the subject into a recovery (sideways) position.

0 / 9Eligibility criteria met