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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222103
• Other study ID #: RDS-Sleep Apnea
• Status: Completed
• Phase: N/A
• First received: August 18, 2014
• Last updated: August 3, 2017
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Scripps Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Home monitoring	Explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights.	10 days