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RecruitingNCT07283289OSAPADUpdated Jul 7, 2026

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

An observational study in Peripheral Artery Disease, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
295
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Artery Disease

Keywords

  • Obstructive Sleep Apnea Syndrome
  • Polygraphy
  • Diagnosis
  • Prevalence
  • Peripheral Arterial Occlusive Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
295 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
    Toulon, Var 83056, France
    • Léonie GEY, M.D. · Contact · leonie.gey@ch-toulon.fr · 04 94 14 50 00
    • Léonie GEY, M.D. · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07283289
Lead sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Responsible party
Sponsor
First posted
Dec 15, 2025
Start date
Nov 5, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 7, 2026

Study contacts

Léonie GEY, M.D.
Contact
leonie.gey@ch-toulon.fr
04 94 14 50 00 ext. +33
Léonie GEY, M.D.
study director · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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