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This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep apnea (OSA).
Consecutive patients referred to a sleep lab for possible OSA (obstructive sleep apnea) will be offered participation in this study. Study subjects will participate in either Part A, Part B or Part C of the study. Subjects will not participate in more than one part of the study. Study sites can participate in multiple parts of the study.
Part A: Sleep Lab
Consecutive patients referred to a sleep lab for possible OSA will be offered participation. Participants who provide informed consent will fill out a questionnaire and then have PSG, as it would normally be performed. During PSG additional sound recordings will be made in three ways:
The sound recordings obtained via the microphone and Smart Phones will be analyzed electronically for OSA by the sponsor's proprietary algorithm. A blinded comparison will be made between the PSG results and SnoreSounds algorithm results.
PSG will be performed and scored in a manner consistent with current (2012) American Academy of Sleep Medicine (AASM) standards. PSGs will be scored twice - with each scoring performed independently. If the Apnea Hypopnea Index (AHI) for each score places the patient in the same OSA severity range [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe] the average of the two scores will be utilized. If however the scores put the patent in different OSA severity ranges, then the study will be scored by an independent sleep medicine physician-sleep technician team and assigned an AHI.
The results of the SnoreSounds testing will not be known to the sleep lab and the results obtained from Snore Sounds analysis will not be utilized in the clinical management of study participants.
Part B: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) (currently not enrolling in Part B)
Part C: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) and to Polysomnography (PSG) (currently not enrolling in Part C)
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15 | Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15 | immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe]. | Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe]. | immediate |
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Inclusion Criteria:
Exclusion Criteria:
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Men and women aged >or= 18 years who are referred for polysomnography (PSG) or Home Sleep Test (HST) because of possible obstructive sleep apnea (OSA).
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| Name | Affiliation | Role |
|---|---|---|
| Ruchir Sehra, MD | Incyphae, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Sleep Center | Burlingame | California | 94010 | United States | ||
| Northeast Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32506203 | Derived | Pandian TNG, Sehra R, Narayan S. Breath variability increases in the minutes preceding obstructive sleep apneic events. Sleep Breath. 2021 Mar;25(1):271-280. doi: 10.1007/s11325-020-02094-1. Epub 2020 Jun 6. | |
| 30022325 | Derived | Narayan S, Shivdare P, Niranjan T, Williams K, Freudman J, Sehra R. Noncontact identification of sleep-disturbed breathing from smartphone-recorded sounds validated by polysomnography. Sleep Breath. 2019 Mar;23(1):269-279. doi: 10.1007/s11325-018-1695-6. Epub 2018 Jul 18. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| New London |
| Connecticut |
| 06320 |
| United States |
| Doctors Community Hospital | Lanham | Maryland | 20706 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |