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

Completed

• Conditions: Obstructive Sleep Apnea of Adult

• Registration Number: NCT02222103
• Lead Sponsor: Scripps Translational Science Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Study Start: 2016-01
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea	10 days	To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.

Secondary Outcome Measures

Name	Time	Method
Home monitoring	10 days	Explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights.

Trial Locations

Locations (1)

Scripps Translational Science Institute; 🇺🇸 La Jolla, California, United States