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NCT02222103 · ClinicalTrials.gov registry record
Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
A clinical trial, sponsored by Scripps Translational Science Institute.
- Completed
- Registry status
- 10
- Enrollment target
NCT02222103 is a clinical trial that has completed, run by Scripps Translational Science Institute. The registered enrollment target is 10 participants.
The verdict
NCT02222103 has completed, sponsored by Scripps Translational Science Institute.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02222103
The ClinicalTrials.gov registry entry for NCT02222103 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scripps Translational Science Institute, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02222103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02222103 about?
NCT02222103 is a clinical study titled "Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles". 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 MultiSens...
What is the current status of trial NCT02222103?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2016-01. Estimated completion is 2016-10.
Who is sponsoring clinical trial NCT02222103?
This trial is sponsored by Scripps Translational Science Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.
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