Obstructive sleep apnea prevalence in people with peripheral artery disease
Prospective Observational Cohort Study on the Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease
This project will test how common obstructive sleep apnea is in adults with peripheral artery disease by using sleep polygraphy during routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 295 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 1 site (Toulon, Var) |
| Trial ID | NCT07283289 on ClinicalTrials.gov |
What this trial studies
This is a preliminary observational cohort enrolling adults with confirmed peripheral arterial occlusive disease at a single French hospital. Participants who are scheduled for routine sleep polygraphy will have overnight respiratory monitoring and their vascular status recorded, including ankle-brachial index when feasible. The study includes patients at all disease stages and excludes those with a prior polygraphy-confirmed OSAS diagnosis currently on nocturnal therapy. No experimental treatments are given; collected data will be pseudonymized and analyzed to estimate OSAS prevalence in this population.
Who should consider this trial
Good fit: Adults (age ≥18) with a confirmed diagnosis of peripheral arterial occlusive disease seen at the participating hospital who are scheduled for routine sleep polygraphy and consent to pseudonymized data use.
Not a fit: Patients already diagnosed with obstructive sleep apnea and receiving nocturnal therapy or those unable to complete ankle-brachial index measurement or sleep polygraphy are unlikely to benefit.
Why it matters
Potential benefit: If successful, it could identify undiagnosed sleep apnea in PAOD patients so they can get treatment that may lower their cardiovascular risk.
How similar studies have performed: Previous research has linked obstructive sleep apnea to atherosclerotic disease and smaller studies have reported higher OSAS rates in PAOD, but results are inconsistent and a definitive prevalence estimate is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with a confirmed diagnosis of PAOD, seen either during hospitalization or in an outpatient vascular medicine consultation. Inclusion is permitted regardless of the disease stage (according to the Leriche and Fontaine classification) or prior surgical intervention. 3. No objection to the use of their pseudonymised medical data 4. Polygraphy scheduled as part of routine care within one month. Exclusion Criteria: 1. Inability to perform the Ankle-Brachial Index (ABI) or sleep polygraphy due to physical or cognitive constraints (e.g., severe dementia, limb malformation, etc.). 2. History of OSAS diagnosis confirmed by polygraphy, and currently receiving nocturnal treatment (e.g., Continuous Positive Airway Pressure - CPAP)
Where this trial is running
Toulon, Var
- Centre Hospitalier Intercommunal Toulon La Seyne sur Mer — Toulon, Var, France (Recruiting)
Study contacts
- Study coordinator: Léonie GEY, M.D.
- Email: leonie.gey@ch-toulon.fr
- Phone: 04 94 14 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.