Study Stopped
Inadequate enrollment without results or statistics being calculated.
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
1 other identifier
observational
83
1 country
4
Brief Summary
Earlier studies suggest that acoustical analysis of snoring sounds can identify obstructive sleep apnea (OSA). The goal of the current study is to refine and validate algorithms for OSA diagnosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2017
CompletedFirst Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 26, 2019
February 1, 2019
1.1 years
February 19, 2018
February 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Eligibility Criteria
The study population includes patients who are referred for polysomnography because of possible obstructive sleep apnea (OSA).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resonea, Inclead
Study Sites (4)
Peninsula Sleep Center
Burlingame, California, 94010, United States
Santa Monica Clinical Trials
Santa Monica, California, 90404, United States
Blue Sleep
New York, New York, 10006, United States
Sounds Sleep Health
Kirkland, Washington, 98034, United States
Related Publications (2)
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.
PMID: 21119221BACKGROUNDAbeyratne 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.
PMID: 23343563BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Freudman, MD
Resonea, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 19, 2018
First Posted
March 7, 2018
Study Start
October 31, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 26, 2019
Record last verified: 2019-02