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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease

• Study Type: Observational
• Enrollment (Estimated): 295

Contacts and Locations

• Study Contact: Name: Léonie GEY, M.D.; Phone Number: +33 04 94 14 50 00; Email: leonie.gey@ch-toulon.fr

Study Locations

• France
  • Var
    • Toulon, Var, France, 83056
      • Recruiting
      • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
      • Contact: Léonie GEY, M.D.; Phone Number: +33 04 94 14 50 00; Email: leonie.gey@ch-toulon.fr
      • Principal Investigator: Léonie GEY, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients diagnosed with OSAS	Patients diagnosed with OSAS by polygraphy, regardless of severity.	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	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.	Up to 1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Léonie GEY, M.D., Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prevalence; Diagnosis; Obstructive Sleep Apnea Syndrome; Peripheral Arterial Occlusive Disease; Polygraphy
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Disease; Sleep Apnea, Obstructive; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1
• Other Study ID Numbers: 2025-CHITS-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No