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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea Central Sleep Apnea Mixed Sleep Apnea Cheyne-Stokes Respiration | Device: SomnaPatch Device: Polysomnography | Not Applicable |
This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.
The study includes the following steps:
Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.
Initial visit, includes:
- Consent discussion and signature
- History, vital signs, and physical exam
Night study
a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.
Additional visits If side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 190 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual. |
Primary Purpose: | Screening |
Official Title: | Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing |
Actual Study Start Date : | February 1, 2016 |
Actual Primary Completion Date : | November 30, 2016 |
Actual Study Completion Date : | November 30, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: SomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
|
Device: SomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. |
Active Comparator: Polysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
|
Device: Polysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. |
- Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) [ Time Frame: 1 night ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to understand and sign the informed consent
- Able to comply with visits and follow ups included in this protocol
- Ages 20-85 years
Exclusion Criteria:
- An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
- Skin rash on the nose or on the maxillary area.
- A history of skin allergy to medical tape, and hypoallergenic tapes.
- A history of skin cancer on the nose or on the maxillary area.
- A history of the base of skull fractures, facial fractures

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034175
United States, Arkansas | |
Preferred Research Partners, Inc | |
Little Rock, Arkansas, United States, 72211 | |
United States, California | |
Peninsula Sleep Center | |
Burlingame, California, United States, 94010 | |
United States, Florida | |
The Good Sheperd Sleep Center, LLC | |
Tampa, Florida, United States, 33635 |
Principal Investigator: | Merhan Farid-Moayer, MD | Peninsula Sleep Center |
Responsible Party: | Somnarus Inc |
ClinicalTrials.gov Identifier: | NCT02034175 |
Other Study ID Numbers: |
SomnaPatch-001-D |
First Posted: | January 13, 2014 Key Record Dates |
Results First Posted: | January 18, 2019 |
Last Update Posted: | October 3, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
apnea hypopnea polysomnography respiratory cheyne |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Apnea, Central Cheyne-Stokes Respiration Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |