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OpenTrials
Completed

NCT Number: NCT05491967

Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome

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.

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Key information

Conditions

Obstructive Sleep Apnea/Hypopnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Valence

Valence, Drome, 26953, France

About this study

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

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. morbimortality vascular criteria

    Time frame: up to 6 months

    Presence or absence of cardiovascular event

  2. morbimortality vascular criteria

    Time frame: up to 6 months

    Presence or absence of neurologic event

  3. morbimortality vascular criteria

    Time frame: up to 6 months

    Presence or absence of ophthalmologic event

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valence

Other

Registry information

Official study title

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

Acronym: SAHOSVAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Sep 8, 2025

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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