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

NCT ID: NCT07283289

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

295 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Léonie GEY, M.D.

Role: STUDY_DIRECTOR

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Locations

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Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Léonie GEY, M.D.

Role: CONTACT

04 94 14 50 00 ext. +33

Facility Contacts

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Léonie GEY, M.D.

Role: primary

04 94 14 50 00 ext. +33

Other Identifiers

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2025-CHITS-014

Identifier Type: -

Identifier Source: org_study_id

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