Back to resultsComparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Primary Purpose
Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SomnaPatch
Polysomnography
Sponsored by
About this trial
This is an interventional screening trial for Obstructive Sleep Apnea focused on measuring apnea, hypopnea, polysomnography, respiratory, cheyne
Eligibility Criteria
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
Sites / Locations
- Preferred Research Partners, Inc
- Peninsula Sleep Center
- The Good Sheperd Sleep Center, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SomnaPatch
Polysomnography
Arm Description
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Outcomes
Primary Outcome Measures
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02034175
Brief Title
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Official Title
Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somnarus Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
Keywords
apnea, hypopnea, polysomnography, respiratory, cheyne
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SomnaPatch
Arm Type
Experimental
Arm Description
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
Arm Title
Polysomnography
Arm Type
Active Comparator
Arm Description
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Intervention Type
Device
Intervention Name(s)
SomnaPatch
Intervention Description
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
Intervention Type
Device
Intervention Name(s)
Polysomnography
Intervention Description
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Primary Outcome Measure Information:
Title
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merhan Farid-Moayer, MD
Organizational Affiliation
Peninsula Sleep Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preferred Research Partners, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Peninsula Sleep Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
The Good Sheperd Sleep Center, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33635
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
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