- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457428
Comprehensive Analysis of Respiratory Events Using Smartphone Systems (CARESS)
Evaluation of Novel Proprietary Biometric as an Aid in the Screening and Diagnosis of Sleep Breathing Disorders
Study Overview
Status
Conditions
Detailed Description
Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) where cessation of breathing occurs during sleep in 9% of middle-aged women and 25% or middle-aged men. Major health issues and risks have been linked to untreated sleep apnea, including drug-resistant hypertension, obesity, congestive heart failure and diabetes.
Patient awareness of this condition is growing, but obtaining adequate data has continuing barriers. The gold standard for sleep testing is the overnight clinical polysomnogram (PSG) where over 20 sensors are attached to a patient and vital signs are monitored and recorded over the course of a 6-8 hour sleep test.
This is a prospective clinical performance study to compare the ability of proprietary algorithms that analyze sleep recordings from smartphones, with FDA cleared Level III home sleep testing (HST) devices, to identify patients with obstructive sleep apnea (OSA).
Consecutive patients referred for home sleep testing (HST) for possible OSA will be offered participation. Participants who provide informed consent will fill out a questionnaire and then proceed with HST in their home. During HST, additional sound recordings will be made with either:
Android type smartphone with a recording application (app). The phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth.
or
- IPhone type smartphone with a recording application (app). Phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth
The sound recordings obtained via smartphones will be analyzed electronically for OSA by the proprietary algorithms. This will be performed by engineers at Resonea, Inc., the study sponsor, who will be blinded to the results obtained by the Level III HST device
HST will be performed using a type III home sleep monitor that has been cleared by the FDA and validated to assist in the diagnosis of OSA. HST results will be interpreted according to the standards established for the device being utilized. HST tests will be interpreted by sleep medicine physicians at the study sites who will be blinded to the assessment from the proprietary algorithms.
The independently determined results of HST and proprietary algorithms analysis will then be compared.
The results of the proprietary algorithm testing will not be known to those providing HST and the proprietary algorithm analysis will not be utilized in the clinical management of study participants
The primary objectives are: (a) to demonstrate that obtaining recordings in home setting for use with the proprietary sound analysis software is feasible and safe; and (b) to compare the results of the proprietary algorithm score with HST for the diagnosis of OSA.
The secondary objectives are: (a) to compare the recorded sound data against various scoring metrics from the HST; and (b) to demonstrate that use of the sound analysis software on smartphones is feasible for patients in the home sleep setting; and (c) to use the proprietary software to identify sleep disordered breathing beyond OSA, including central sleep apnea, snoring and other conditions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Burlingame, California, United States, 94010
- Peninsula Sleep Center
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Santa Monica, California, United States, 90404
- Santa Monica Clinical Trials
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New York
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New York, New York, United States, 10006
- Blue Sleep
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Washington
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Kirkland, Washington, United States, 98034
- Sounds Sleep Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- referred for polysomnography (PSG) because of possible obstructive sleep apnea (OSA)
owns/possesses a smartphone for use during the study. Must be:
- Android models running Android OS Samsung Galaxy 5 or later
- iPhone models running iOS 6 or later
Exclusion Criteria:
- previous PSG or home sleep testing (HST) confirmation of OSA
- prior surgery for snoring or OSA
- medical contraindication of HST, as applicable
- congnitive impairment that might interfere with obtaining informed consent, or completing Clinical Questionnaire
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of agreement between Sleep Breathing Index Score obtained from analysis by the proprietary algorith, and the Apnea-Hypopnea Index (AHI) as obtained by HST, with a cut-off of 15
Time Frame: immediate
|
Level of agreement between the Sleep Breathing Index Score obtained from analysis by the proprietary algorithm, and the Apnea-Hypopnea Index (AHI) as obtained by HST, with a cut-off of 15.
|
immediate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon Freudman, MD, Resonea, Inc
Publications and helpful links
General Publications
- Karunajeewa AS, Abeyratne UR, Hukins C. Multi-feature snore sound analysis in obstructive sleep apnea-hypopnea syndrome. Physiol Meas. 2011 Jan;32(1):83-97. doi: 10.1088/0967-3334/32/1/006. Epub 2010 Nov 30.
- Abeyratne UR, de Silva S, Hukins C, Duce B. Obstructive sleep apnea screening by integrating snore feature classes. Physiol Meas. 2013 Feb;34(2):99-121. doi: 10.1088/0967-3334/34/2/99. Epub 2013 Jan 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARESS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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