Peripheral Artery DiseaseOSAPADNCT07283289
Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease
An observational study of Peripheral Artery Disease, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is characterized by partial (hypopnea) or complete (apnea) obstruction of the upper airways, leading to intermittent hypoxemia and sleep fragmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 295 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2025to Nov 2026
- Phase
- Observational
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: Patients with a confirmed diagnosis of PAOD, seen either during hospitalization or in an outpatient vascular medicine consultation.
Who may be able to join
- Age ≥ 18 years
- 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.
- No objection to the use of their pseudonymised medical data
- Polygraphy scheduled as part of routine care within one month.
Who cannot join
- Inability to perform the Ankle-Brachial Index (ABI) or sleep polygraphy due to physical or cognitive constraints (e.g., severe dementia, limb malformation, etc.).
- History of OSAS diagnosis confirmed by polygraphy, and currently receiving nocturnal treatment (e.g., Continuous Positive Airway Pressure - CPAP)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
Léonie GEY, M.D., 04 94 14 50 00 ext. +33, leonie.gey@ch-toulon.fr
Léonie GEY, M.D.
About this study
Official title: Prospective Observational Cohort Study on the Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease
Obstructive sleep apnea syndrome (OSAS) is characterized by partial (hypopnea) or complete (apnea) obstruction of the upper airways, leading to intermittent hypoxemia and sleep fragmentation. Peripheral arterial occlusive disease (PAOD) is a chronic condition defined by the narrowing or occlusion of arteries in the lower limbs, often resulting in ischemia of downstream tissues. This disease is a common complication of atherosclerosis and affects approximately 1.2% of the general French population.
OSAS is a well-established risk factor for atherosclerotic disease, particularly for coronary and neurovascular events. Although a relationship between OSAS and PAOD has been investigated in recent years, the link has not been definitively established and requires further study. Therefore, this preliminary cohort study aims to observe the prevalence of OSAS among patients diagnosed with PAOD, regardless of the disease stage.
- Conditions
- Peripheral Artery Disease
- Keywords
- Obstructive Sleep Apnea Syndrome, Polygraphy, Diagnosis, Prevalence, Peripheral Arterial Occlusive Disease
- Medical subject headings
- Peripheral Arterial Disease, Sleep Apnea, Obstructive, Disease, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PAOD | Patients hospitalized or seen in vascular medicine consultation with a diagnosis of PAOD at all stages (operated or not) according to the Leriche and Fontaine classification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients diagnosed with OSAS
Patients diagnosed with OSAS by polygraphy, regardless of severity.
Measured: Up to 1 month
Secondary outcomes (4)
Proportion of patients diagnosed with OSAS, stratified by the presence or absence of cardiovascular comorbidities.
The prevalence of OSAS will be analyzed in patients with PAOD, stratified by the presence or absence of cardiovascular involvement (e.g., carotid plaque, carotid stenosis, or abdominal aortic aneurysm).
Measured: Up to 1 month
Ankle-brachial index
The Ankle-Brachial Index (ABI) will be analyzed according to OSAS severity, which is defined by the Apnea-Hypopnea Index (AHI):
- Mild: 5 to 14 events per hour
- Moderate: 15 to 30 events per hour
- Severe: > 30 events per hour
Measured: Day 0
Toe-brachial index
The toe-Brachial Index (TBI) will be analyzed according to OSAS severity, which is defined by the Apnea-Hypopnea Index (AHI):
- Mild: 5 to 14 events per hour
- Moderate: 15 to 30 events per hour
- Severe: > 30 events per hour
Measured: Day 0
Proportion of patients diagnosed with OSAS according to PAOD severity
The prevalence of OSAS (diagnosed by polygraphy) will be analyzed according to the severity stage of PAOD.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start5 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- 295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léonie GEY, M.D., Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283289
- Sponsor's protocol ID
- 2025-CHITS-014
- Acronym
- OSAPAD
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No