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Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

Prospective Observational Cohort Study on the Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07283289
Acronym
OSAPAD
Enrollment
295
Registered
2025-12-15
Start date
2025-11-05
Completion date
2026-11-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

Obstructive Sleep Apnea Syndrome, Polygraphy, Diagnosis, Prevalence, Peripheral Arterial Occlusive Disease

Brief 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. 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.

Interventions

None listed

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients diagnosed with OSASUp to 1 monthPatients diagnosed with OSAS by polygraphy, regardless of severity.

Secondary

MeasureTime frameDescription
Proportion of patients diagnosed with OSAS, stratified by the presence or absence of cardiovascular comorbidities.Up to 1 monthThe 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).
Ankle-brachial indexDay 0The 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
Toe-brachial indexDay 0The 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
Proportion of patients diagnosed with OSAS according to PAOD severityUp to 1 monthThe prevalence of OSAS (diagnosed by polygraphy) will be analyzed according to the severity stage of PAOD.

Countries

France

Contacts

CONTACTLéonie GEY, M.D.
leonie.gey@ch-toulon.fr04 94 14 50 00
STUDY_DIRECTORLéonie GEY, M.D.

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026