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

Completed

Conditions studied: Obstructive Sleep Apnea of Adult

In brief

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.

Key facts

Study ID

NCT02222103

Run by

Scripps Translational Science Institute

People needed

10

Starts

2016-01-01

Expected to finish

2016-10-01

Last updated by the study team

2017-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Scripps Translational Science Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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