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NCT Number: NCT07283289

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.

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Key information

Conditions

Peripheral Artery Disease Apnea Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Disease Dyssomnias Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Arterial Occlusive Disease 1 Peripheral Vascular Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location status: Recruiting

Location contact

Léonie GEY, M.D.

CONTACT

[email protected]

04 94 14 50 00 ext. +33

Léonie GEY, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Proportion of patients diagnosed with OSAS

    Time frame: Up to 1 month

    Patients diagnosed with OSAS by polygraphy, regardless of severity.

Secondary outcomes

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

    Time frame: Up to 1 month

    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).

  2. Ankle-brachial index

    Time frame: Day 0

    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

  3. Toe-brachial index

    Time frame: Day 0

    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

  4. Proportion of patients diagnosed with OSAS according to PAOD severity

    Time frame: Up to 1 month

    The prevalence of OSAS (diagnosed by polygraphy) will be analyzed according to the severity stage of PAOD.

Study contacts

Contact information is provided by the study sponsor or research team.

Léonie GEY, M.D.

CONTACT

[email protected]

04 94 14 50 00 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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

Acronym: OSAPAD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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