Obstructive Sleep ApneaCARESSNCT03457428
Comprehensive Analysis of Respiratory Events Using Smartphone Systems
An observational study of Obstructive Sleep Apnea, run by Resonea, Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 83 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Oct 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes patients who are referred for polysomnography because of possible obstructive sleep apnea (OSA).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Peninsula Sleep Center
Burlingame, California, 94010
Sounds Sleep Health
Kirkland, Washington, 98034
Blue Sleep
New York, New York, 10006
Santa Monica Clinical Trials
Santa Monica, California, 90404
About this study
Official title: Evaluation of Novel Proprietary Biometric as an Aid in the Screening and Diagnosis of Sleep Breathing Disorders
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, home sleep testing
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start31 Oct 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: Inadequate enrollment without results or statistics being calculated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resonea, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jonathan Freudman, Resonea, Inc
- Investigators
- Jon Freudman, MD, Principal investigator, Resonea, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457428
- Sponsor's protocol ID
- CARESS
- Acronym
- CARESS
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21119221Abeyratne 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.
PubMed 23343563
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Proprietary Biometric as an Aid in the Screening and Diagnosis of Sleep Breathing Disorders
- ClinicalTrials.gov ID
- NCT03457428
- Acronym / sponsor ID
- CARESS / CARESS
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, home sleep testing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment without results or statistics being calculated.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Resonea, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients who are referred for polysomnography because of possible obstructive sleep apnea (OSA).
Key inclusion criteria (4 listed)
- referred for polysomnography (PSG) because of possible obstructive sleep apnea (OSA)
- owns/possesses a smartphone for use during the study. Must be:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Inadequate enrollment without results or statistics being calculated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 21119221Karunajeewa 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.
- Background: PubMed 23343563Abeyratne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Freudman, MD principal investigator
Resonea, Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Resonea, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment without results or statistics being calculated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457428, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.