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

NCT02222103 | Completed

• 1 other identifier: RDS-Sleep Apnea
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea

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

  10 days

Secondary Outcomes (1)

• Home monitoring

  10 days

Study Arms (1)

Suspected obstructive sleep apnea in adults

Already scheduled in-lab sleep study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults over age 18
• Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Scripps Clinic: collaborator

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Study Officials

• Steven Steinhubl, MD

  STSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Digital Medicine

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)