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
- Trial ID:
- Steven Steinhubl
- Adults over age 18
- Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.
- 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.