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Clinical Trials/NCT02222103
NCT02222103
Completed
Not Applicable

Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles

Scripps Translational Science Institute1 site in 1 country10 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea of Adult
Sponsor
Scripps Translational Science Institute
Enrollment
10
Locations
1
Primary Endpoint
Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm Diagnostic Systems, Inc. which has many sensors inside in a "Band-Aid" like strip in order to see if it can help diagnose capabilities in individuals suspected of having obstructive sleep apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered, flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and motion/position. One advantage of this device over current home diagnostic systems is the capability for recording over several nights.

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
October 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Scripps Translational Science Institute
Responsible Party
Principal Investigator
Principal Investigator

Steven Steinhubl

Director, Digital Medicine

Scripps Translational Science Institute

Eligibility Criteria

Inclusion Criteria

  • Adults over age 18
  • Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.

Exclusion Criteria

  • Congestive heart failure or other major medical illness that would complicate the diagnosis of OSA.
  • Psychological or social situation that would make the study difficult for the patient.

Outcomes

Primary Outcomes

Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea

Time Frame: 10 days

To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.

Secondary Outcomes

  • Home monitoring(10 days)

Study Sites (1)

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