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

NCT ID: NCT05491967

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2023-03-16

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea/Hypopnea Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Continuous Positive Airway Pressure (CPAP)

Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP

No interventions assigned to this group

Mandibular Advancement Orthosis

Obstructive Sleep Apnea/Hypopnea Syndrome treated with Mandibular Advancement Orthosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Valence

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ch Valence

Valence, Drome, France

Site Status

Countries

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France

Other Identifiers

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RIPH-CHV-07

Identifier Type: -

Identifier Source: org_study_id

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