Central Sleep Apnea, Cheyne-Stokes Respiration, Mixed Sleep Apnea, Obstructive Sleep Apnea
Conditions
Keywords
apnea, hypopnea, polysomnography, respiratory, cheyne
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: 1. Consent discussion and signature 2. 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.
Interventions
DEVICESomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
DEVICEPolysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Sponsors
Somnarus Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) | 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 |
Countries
United States
Participant flow
Recruitment details
This is a multi-site study conducted in the United States. Study enrollment began February 2016 and concluded November 2016.
Participants by arm
| Arm | Count |
|---|---|
| SomnaPatch and PSG Simultaneously All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor | 190 |
| Total | 190 |
Baseline characteristics
| Characteristic | SomnaPatch and PSG Simultaneously |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 146 Participants |
| Region of Enrollment United States | 190 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 190 |
| other Total, other adverse events | 0 / 190 |
| serious Total, serious adverse events | 0 / 190 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SomnaPatch and PSG Simultaneously | Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) | 87.1 percentage of device agreements |