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Clinical Trials/NCT05491967
NCT05491967
Completed
Not Applicable

Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis

Centre Hospitalier de Valence1 site in 1 country172 target enrollmentMarch 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea/Hypopnea Syndrome
Sponsor
Centre Hospitalier de Valence
Enrollment
172
Locations
1
Primary Endpoint
morbimortality vascular criteria
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

Detailed Description

The first-line treatment of severe Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) is nocturnal ventilation with Continuous Positive Airway Pressure (CPAP). and The second-line treatment is the mandibular advancement orthosis (MAO)\]. CPAP is the most effective treatment to reduce the apnea-hypopnea index (AHI). However, its tolerance is sometimes difficult, causing many discontinuations. The purpose of this review is to evaluate a vascular morbimortality criteria: * Cardiovascular: myocardial infarction, heart failure, rhythm disorder * Neurological: transient or non transient stroke * ophthalmologic: anterior ischemic optic neuropathy, occlusion of the central artery or central retinal vein occlusion

Registry
clinicaltrials.gov
Start Date
March 16, 2021
End Date
March 16, 2023
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis
  • Age ≥ 18 years old
  • Read, write and understand the French language

Exclusion Criteria

  • Patient under guardianship, deprived of liberty, safeguard of justice
  • Refusal to participate in research

Outcomes

Primary Outcomes

morbimortality vascular criteria

Time Frame: up to 6 months

Presence or absence of ophthalmologic event

Study Sites (1)

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