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

Sponsor

Centre Hospitalier de Valence (Other)

Overall Status

Recruiting

CT.gov ID

NCT05491967

Collaborator

(none)

172

Enrollment

Location

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea/Hypopnea Syndrome

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

172 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Mar 16, 2021

Actual Primary Completion Date :

Mar 16, 2022

Anticipated Study Completion Date :

Mar 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Continuous Positive Airway Pressure (CPAP) Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP
Mandibular Advancement Orthosis Obstructive Sleep Apnea/Hypopnea Syndrome treated with Mandibular Advancement Orthosis

Outcome Measures

Primary Outcome Measures

morbimortality vascular criteria [up to 6 months]
Presence or absence of cardiovascular event
morbimortality vascular criteria [up to 6 months]
Presence or absence of neurologic event
morbimortality vascular criteria [up to 6 months]
Presence or absence of ophthalmologic event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ch Valence	Valence	Drome	France	26953

Sponsors and Collaborators

Centre Hospitalier de Valence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier de Valence

ClinicalTrials.gov Identifier:

NCT05491967

Other Study ID Numbers:

00007

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier de Valence

cardiovascular risk

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Syndrome

Study Results

No Results Posted as of Aug 12, 2022