Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/5/2017 |
| Start Date: | January 2016 |
| End Date: | October 2016 |
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.
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.
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.
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