Obstructive Sleep ApneaDASCANCT06779682
Systematic Screening for Obstructive Sleep Apnea During Preoperative Consultation Using AI-preoperative Agents
An observational study of Obstructive Sleep Apnea and Preoperative Evaluation, run by Intelligence Anesthesia at 1 site in France.
Trial summary
The goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Preoperative Evaluation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 1 Sep 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients with a STOP BANG > 5 or > 4 associated with an obesity (BMI > 35 kg/m2)
Who may be able to join
- All patients with a national health identifier affiliated with the social security system, aged over 18, including French individuals over 50 years old, in scheduled anesthesia consultation with STOP BANG > 5 or > 4 with BMI > 35
Who cannot join
- Refusal to participate in the study, age under 50, not affiliated with the social security system, minor or under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Systematic Screening for Obstructive Sleep Apnea (OSA) During Preoperative Consultation
The goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective surgery. The main questions it aims to answer are:
- Does the systematic screening protocol increase the proportion of patients identified as being at high risk for OSA compared to standard care?
- What is the impact of systematic screening on postoperative outcomes, including complications, length of stay, and mortality?
Read more
Researchers will compare standard care practices (before implementation) to the systematic screening protocol (after implementation) to determine the effect on OSA detection rates and clinical outcomes.
Participants will:
- Complete the STOP-BANG questionnaire during their anesthesia consultation.
- (Optional) Have a facial photograph taken to analyze morphometric characteristics that may correlate with OSA risk.
- Be referred for further diagnostic testing if identified as high-risk for OSA.
- Conditions
- Obstructive Sleep Apnea, Preoperative Evaluation
- Keywords
- preoperative, STOP-BANG score, Obstructive Sleep Apnea, AI, OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of participants in whom the risk of OSA (Obstructive Sleep Apnea Syndrome) was detected in the control group before versus the group after
Measured: From enrollment to the end of treatment at 7 months
Secondary outcomes (6)
Mortality at 3 months.
Measured: From enrollment to the end of treatment at 7 months
Postoperative length of stay.
Measured: From enrollment to the end of treatment at 7 months
Sensitivity, specificity, and concordance rate of OSA (Obstructive Sleep Apnea Syndrome) detection.
Measured: From enrollment to the end of treatment at 7 months
Correlation between facial morphotype and OSA diagnosis with and without facial morphotype measurement.
Measured: From enrollment to the end of treatment at 7 months
Postoperative complications and mortality at 3 months.
Measured: From enrollment to the end of treatment at 7 months
Postoperative complications
Pulmonary event Cardiac event Kidney event Vascular event
Measured: From enrollment to the end of treatment at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2024
- Study completion1 Sep 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Intelligence Anesthesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Anesthesiology, Hopital Foch, Suresnes, France., GCS Ramsay Santé pour l'Enseignement et la Recherche, Hôpital privé Claude Galien - Quincy-sous-Sénart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779682
- Sponsor's protocol ID
- 2020-A01959-30
- Acronym
- DASCA
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Systematic Screening for Obstructive Sleep Apnea (OSA) During Preoperative Consultation
- ClinicalTrials.gov ID
- NCT06779682
- Acronym / sponsor ID
- DASCA / 2020-A01959-30
- Conditions
- Obstructive Sleep Apnea, Preoperative Evaluation
- Keywords
- preoperative, STOP-BANG score, Obstructive Sleep Apnea, AI, OSA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Intelligence AnesthesiaIndustry (pharma, biotech, devices)
- Collaborators
- Department of Anesthesiology, Hopital Foch, Suresnes, France., GCS Ramsay Santé pour l'Enseignement et la Recherche, Hôpital privé Claude Galien - Quincy-sous-Sénart
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Jan 2025 (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 goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective surgery. The main questions it aims to answer are:
- Does the systematic screening protocol increase the proportion of patients identified as being at high risk for OSA compared to standard care?
- What is the impact of systematic screening on postoperative outcomes, including complications, length of stay, and mortality?
Researchers will compare standard care practices (before implementation) to the systematic screening protocol (after implementation) to determine the effect on OSA detection rates and clinical outcomes.
Participants will:
- Complete the STOP-BANG questionnaire during their anesthesia consultation.
- (Optional) Have a facial photograph taken to analyze morphometric characteristics that may correlate with OSA risk.
- Be referred for further diagnostic testing if identified as high-risk for OSA.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a STOP BANG > 5 or > 4 associated with an obesity (BMI > 35 kg/m2)
Key inclusion criteria (1 listed)
- All patients with a national health identifier affiliated with the social security system, aged over 18, including French individuals over 50 years old, in scheduled anesthesia consultation with STOP BANG > 5 or > 4 with BMI > 35
Key exclusion criteria (1 listed)
- Refusal to participate in the study, age under 50, not affiliated with the social security system, minor or under legal protection
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
proportion of participants in whom the risk of OSA (Obstructive Sleep Apnea Syndrome) was detected in the control group before versus the group after
Time frame: From enrollment to the end of treatment at 7 months
6 secondary outcomes
Mortality at 3 months.
Time frame: From enrollment to the end of treatment at 7 months
Postoperative length of stay.
Time frame: From enrollment to the end of treatment at 7 months
Sensitivity, specificity, and concordance rate of OSA (Obstructive Sleep Apnea Syndrome) detection.
Time frame: From enrollment to the end of treatment at 7 months
Correlation between facial morphotype and OSA diagnosis with and without facial morphotype measurement.
Time frame: From enrollment to the end of treatment at 7 months
Postoperative complications and mortality at 3 months.
Time frame: From enrollment to the end of treatment at 7 months
Postoperative complications
Time frame: From enrollment to the end of treatment at 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Preoperative Evaluation, run by Intelligence Anesthesia at 1 site in 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 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
proportion of participants in whom the risk of OSA (Obstructive Sleep Apnea Syndrome) was detected in the control group before versus the group after (time frame: From enrollment to the end of treatment at 7 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 17 Jan 2025.