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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: Completed study, sponsored by Scripps Translational Science Institute.

NCT02222103 is a clinical trial that has completed, run by Scripps Translational Science Institute. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-01
Est. Completion 2016-10

What the finished NCT02222103 record still lists

NCT02222103 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02222103 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT02222103, the US trial registry maintained by the National Library of Medicine. NCT02222103 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.