Obstructive Sleep ApneaNCT05711329
Comparison of Methodology Proposed by the SFAR for the Detection by Videoconference of Obstructive Sleep Apnea.
An observational study of Obstructive Sleep Apnea, run by Astes.
Trial summary
The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients. 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
- What is being tested?
- Accuracy
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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: Population to validate the method proposed by the SFAR to detect OSA patients via videoconference.
Who may be able to join
- All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography
Who cannot join
- Patient's refusal
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Aim of This Study is to Determine the Accuracy of the Self-reported Parameters (Compared to Measurement Performed by the Physician) and the Influence of OSA Screening Scores.
The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.
Read the detailed description
The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.
Other methods, such as a predictive score, also exist. The accuracy of the French method compared to PSG and the predictive scores is to be determined.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Accuracy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuracyOther
We will validate the accuracy of the method proposed by the SFAR to detect OSA patients via videoconference (in comparison with the results of the PSG).
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients in this group will serve to validate the accuracy of the French method to detect OSA patients in comparison with PSG results. Receives: Other: Accuracy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the method proposed by the SFAR by comparison with results of polysomnography.
Validation (or not) of the method proposed by the SFAR to detect OSA patient va videoconference.
The SFAR proposed a method to detect OSA patients throughout a videoconference. This method consists in requesting the patient to go around his neck with his two hands. However, this method has not been validated. The outcome of the study is to validate or invalidate the method proposed by the SFAR in comparison with the results of polysomnography (which remains the gold standard for the diagnosis of OSA patients).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Nov 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, FAHA, FAACD, Astes
- Investigators
- Eric Deflandre, MD, PhD, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711329
- Sponsor's protocol ID
- Visio-PSG
- Status last verified
- Apr 2024
- First submitted
- 24 Jan 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aim of This Study is to Determine the Accuracy of the Self-reported Parameters (Compared to Measurement Performed by the Physician) and the Influence of OSA Screening Scores.
- ClinicalTrials.gov ID
- NCT05711329
- Acronym / sponsor ID
- Visio-PSG
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Feb 2023 (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.
The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.
Detailed description
The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.
Other methods, such as a predictive score, also exist. The accuracy of the French method compared to PSG and the predictive scores is to be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: AccuracyPatients in this group will serve to validate the accuracy of the French method to detect OSA patients in comparison with PSG results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population to validate the method proposed by the SFAR to detect OSA patients via videoconference.
Key inclusion criteria (1 listed)
- All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography
Key exclusion criteria (1 listed)
- Patient's refusal
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 |
|---|---|---|
| AccuracyWe will validate the accuracy of the method proposed by the SFAR to detect OSA patients via videoconference (in comparison with the results of the PSG). | Other | All patients |
Primary outcome
Validation of the method proposed by the SFAR by comparison with results of polysomnography.
Time frame: 1 month
Validation (or not) of the method proposed by the SFAR to detect OSA patient va videoconference. The SFAR proposed a method to detect OSA patients throughout a videoconference. This method consists in requesting the patient to go around his neck with his two hands. However, this method has not been validated. The outcome of the study is to validate or invalidate the method proposed by the SFAR in comparison with the results of polysomnography (which remains the gold standard for the diagnosis of OSA patients).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Eric Deflandre, MD, PhD principal investigator
Astes
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Astes.
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 1 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 23 Apr 2024. 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 Eric Deflandre, MD, PhD (003281209563, eric.deflandre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the method proposed by the SFAR by comparison with results of polysomnography. (time frame: 1 month). 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 23 Apr 2024.