An observational study in Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, sponsored by Incyphae, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Incyphae, Inc. · Observational
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)
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).
Exclusion Criteria:
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
Time frame: immediate
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 \[0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, \>30 severe\].
Time frame: immediate
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.