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

Obstructive Sleep Apnea/Hypopnea Syndrome Clinical Trial

— SAHOSVAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491967
• Other study ID #: 00007
• Status: Completed
• Start date: March 16, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier de Valence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea/Hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
France	Ch Valence	Valence	Drome

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valence

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbimortality vascular criteria	Presence or absence of cardiovascular event	up to 6 months
Primary	morbimortality vascular criteria	Presence or absence of neurologic event	up to 6 months
Primary	morbimortality vascular criteria	Presence or absence of ophthalmologic event	up to 6 months