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Trial record 1 of 1 for:    NCT02034175
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Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034175
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : January 18, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Somnarus Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Screening
Conditions Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
Cheyne-Stokes Respiration
Interventions Device: SomnaPatch
Device: Polysomnography
Enrollment 190
Recruitment Details This is a multi-site study conducted in the United States. Study enrollment began February 2016 and concluded November 2016.
Pre-assignment Details  
Arm/Group Title SomnaPatch and PSG Simultaneously
Hide Arm/Group Description All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Period Title: Overall Study
Started 190
Completed 190
Not Completed 0
Arm/Group Title SomnaPatch and PSG Simultaneously
Hide Arm/Group Description All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
54.1  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
84
  44.2%
Male
106
  55.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Hispanic or Latino
18
   9.5%
Not Hispanic or Latino
172
  90.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
American Indian or Alaska Native
1
   0.5%
Asian
26
  13.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
   5.3%
White
146
  76.8%
More than one race
7
   3.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 190 participants
190
1.Primary Outcome
Title Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
Hide Description 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
Time Frame 1 night
Hide Outcome Measure Data
Hide Analysis Population Description
12 participants were excluded due to poor quality of sleep data or technical issues during the night. Sleep data was unable to be scored.
Arm/Group Title SomnaPatch and PSG Simultaneously
Hide Arm/Group Description:
All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
Overall Number of Participants Analyzed 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of device agreements
87.1
(81.2 to 91.6)
Time Frame All adverse events were collected over the 1 night period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SomnaPatch and PSG Simultaneously
Hide Arm/Group Description All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor
All-Cause Mortality
SomnaPatch and PSG Simultaneously
Affected / at Risk (%)
Total   0/190 (0.00%) 
Hide Serious Adverse Events
SomnaPatch and PSG Simultaneously
Affected / at Risk (%)
Total   0/190 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SomnaPatch and PSG Simultaneously
Affected / at Risk (%)
Total   0/190 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria Merchant
Organization: Somnarus Inc
Phone: 4087610884
EMail: somnarus@gmail.com
Layout table for additonal information
Responsible Party: Somnarus Inc
ClinicalTrials.gov Identifier: NCT02034175    
Other Study ID Numbers: SomnaPatch-001-D
First Submitted: January 9, 2014
First Posted: January 13, 2014
Results First Submitted: July 25, 2018
Results First Posted: January 18, 2019
Last Update Posted: October 3, 2019