Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles

August 3, 2017 updated by: Steven Steinhubl, Scripps Translational Science Institute

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Translational Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be adults men and women suspected of having obstructive sleep apnea and already scheduled for an in-lab sleep study at the Scripps Clinic Viterbi Family Sleep Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suspected obstructive sleep apnea in adults
Already scheduled in-lab sleep study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

Scripps Clinic

Investigators

  • Principal Investigator: Steven Steinhubl, MD, STSI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDS-Sleep Apnea

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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