Trial Outcomes & Findings for Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing (NCT NCT02034175)

NCT ID: NCT02034175

Last Updated: 2019-10-03

Results Overview

AHI is the number of apneas and hypopneas that occur over an hour during the course of the night. The SomnaPatch and PSG were wore simultaneously over the night. The results from the SomnaPatch and PSG were compared per individual for agreement

Recruitment status

COMPLETED

Study phase

Target enrollment

190 participants

Primary outcome timeframe

1 night

Results posted on

2019-10-03

Participant Flow

This is a multi-site study conducted in the United States. Study enrollment began February 2016 and concluded November 2016.

Participant milestones

Participant milestones
Measure	SomnaPatch and PSG Simultaneously All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Overall Study STARTED	190
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SomnaPatch and PSG Simultaneously n=190 Participants All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Age, Continuous	54.1 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	190 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

Population: 12 participants were excluded due to poor quality of sleep data or technical issues during the night. Sleep data was unable to be scored.

Outcome measures

Outcome measures
Measure	SomnaPatch and PSG Simultaneously n=178 Participants All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)	87.1 percentage of device agreements Interval 81.2 to 91.6

Adverse Events

SomnaPatch and PSG Simultaneously

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Merchant

Somnarus Inc

Phone: 4087610884

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor is responsible for publishing the study results and the PIs are not allowed to publish the study data without an approval from the sponsor
Publication restrictions are in place

Restriction type: OTHER