Sleep ApneaNCT04759482
Validation of a New Algorithm for Screening Sleep Apnea Syndrome From Electrocardiogram
An observational study of Sleep Apnea, run by Central Hospital, Nancy, France.
Trial summary
Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- polysomnography
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient refered to the CSMR, for which sleep apnea are supected
Who may be able to join
- all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020
- results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5
Who cannot join
- refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of an Innovative Algorithm for Screening Sleep Apnea Syndrome From an Electrocardiographic Recording During Sleep
Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).
- Conditions
- Sleep Apnea
- Being tested
- polysomnography
- Keywords
- sleep, electrocardiogram, screening, apnea, polysomnography, algorithm
- Medical subject headings
- Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDiagnostic test
Polysomnography consisted in recording sleep parameters during one night, using a non-invasive multi-channels device, including respiratory sensors, electrocardiogram and electroencephalogram
| Study group | Role | What they receive |
|---|---|---|
| Patients with sleep apnea | We selected 150 patients recorded by polysomnography between january 2019 and june 2020 in the Center for Sleep Medecine and Research in Nancy. Receives: Diagnostic Test: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El Mehdi Siaghy, Study chair, Research and Innovation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759482
- Sponsor's protocol ID
- 2020PI046
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Innovative Algorithm for Screening Sleep Apnea Syndrome From an Electrocardiographic Recording During Sleep
- ClinicalTrials.gov ID
- NCT04759482
- Acronym / sponsor ID
- 2020PI046
- Conditions
- Sleep Apnea
- Keywords
- sleep, electrocardiogram, screening, apnea, polysomnography, algorithm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Feb 2021 (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.
Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sleep apnea | – | Diagnostic Test: polysomnographyWe selected 150 patients recorded by polysomnography between january 2019 and june 2020 in the Center for Sleep Medecine and Research in Nancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient refered to the CSMR, for which sleep apnea are supected
Key inclusion criteria (2 listed)
- all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020
- results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnographyPolysomnography consisted in recording sleep parameters during one night, using a non-invasive multi-channels device, including respiratory sensors, electrocardiogram and electroencephalogram | Diagnostic test | Patients with sleep apnea |
Primary outcome
Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
El Mehdi Siaghy study chair
Research and Innovation Department
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Central Hospital, Nancy, France.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Carpentier (0033383858585, n.carpentier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.