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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SomnaPatch | Experimental | SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. |
|
| Polysomnography | Active Comparator | Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SomnaPatch | Device | SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merhan Farid-Moayer, MD | Peninsula Sleep Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preferred Research Partners, Inc | Little Rock | Arkansas | 72211 | United States | ||
| Peninsula Sleep Center |
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This is a multi-site study conducted in the United States. Study enrollment began February 2016 and concluded November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SomnaPatch and PSG Simultaneously | All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SomnaPatch and PSG Simultaneously | All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 12 participants were excluded due to poor quality of sleep data or technical issues during the night. Sleep data was unable to be scored. | Posted | Number | 95% Confidence Interval | percentage of device agreements | 1 night |
|
All adverse events were collected over the 1 night period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SomnaPatch and PSG Simultaneously | All patients enrolled in the clinical trial underwent simultaneous testing with both polysomnography and SomnaPatch portable sleep monitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Merchant | Somnarus Inc | 4087610884 | somnarus@gmail.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| D012891 | Sleep Apnea Syndromes |
| D002639 | Cheyne-Stokes Respiration |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual.
| Polysomnography | Device | Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. |
|
| Burlingame |
| California |
| 94010 |
| United States |
| The Good Sheperd Sleep Center, LLC | Tampa | Florida | 33635 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 190 |
| 0 |
| 190 |
| 0 |
| 190 |
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
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |