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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients with a confirmed diagnosis of PAOD, seen either during hospitalization or in an outpatient vascular medicine consultation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

295 Participants
are grouped into 1 trial group
Group A: Patients with PAOD

Trial outcomes

Primary outcomes

1

Proportion of patients diagnosed with OSAS

Patients diagnosed with OSAS by polygraphy, regardless of severity.

Time frame
Up to 1 month

Secondary outcomes

1

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).

Time frame
Up to 1 month
2

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

Time frame
Day 0
3

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

Time frame
Day 0
4

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.

Time frame
Up to 1 month

Other outcomes

Sponsors and contacts

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