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OpenTrials
Completed

NCT Number: NCT02222103

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea

    Time frame: 10 days

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

Secondary outcomes

  1. Home monitoring

    Time frame: 10 days

    Explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights.

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • Scripps Clinic

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2014
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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