Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
NCT ID: NCT02222103
Last Updated: 2017-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2016-01-31
2016-10-31
Brief Summary
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The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. Subjects will wear the device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects will go about their normal daily activities and return the device via mail once completed.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Suspected obstructive sleep apnea in adults
Already scheduled in-lab sleep study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.
Exclusion Criteria
* Psychological or social situation that would make the study difficult for the patient.
18 Years
ALL
Yes
Sponsors
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Scripps Clinic
OTHER
Scripps Translational Science Institute
OTHER
Responsible Party
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Steven Steinhubl
Director, Digital Medicine
Principal Investigators
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Steven Steinhubl, MD
Role: PRINCIPAL_INVESTIGATOR
STSI
Locations
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Scripps Translational Science Institute
La Jolla, California, United States
Countries
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Other Identifiers
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RDS-Sleep Apnea
Identifier Type: -
Identifier Source: org_study_id
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