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

NCT07283289 | Recruiting

• 1 other identifier: 2025-CHITS-014
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients diagnosed with OSAS

  Patients diagnosed with OSAS by polygraphy, regardless of severity.

  Up to 1 month

Secondary Outcomes (4)

• Proportion of patients diagnosed with OSAS, stratified by the presence or absence of cardiovascular comorbidities.

  Up to 1 month

• Ankle-brachial index

  Day 0

• Toe-brachial index

  Day 0

• Proportion of patients diagnosed with OSAS according to PAOD severity

  Up to 1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years
• No objection to the use of their pseudonymised medical data
• Polygraphy scheduled as part of routine care within one month.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Sleep Apnea, Obstructive; Disease; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Léonie GEY, M.D.

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Central Study Contacts

Léonie GEY, M.D.

CONTACT

04 94 14 50 00; leonie.gey@ch-toulon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)