NCT05491967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 8, 2022

Last Update Submit

September 5, 2025

Conditions

Obstructive Sleep Apnea/Hypopnea Syndrome

Keywords

cardiovascular risk

Outcome Measures

Primary Outcomes (3)

  • morbimortality vascular criteria

    Presence or absence of cardiovascular event

    up to 6 months

  • morbimortality vascular criteria

    Presence or absence of neurologic event

    up to 6 months

  • morbimortality vascular criteria

    Presence or absence of ophthalmologic event

    up to 6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Valence

Valence, Drome, 26953, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

August 8, 2022

Study Start

March 16, 2021

Primary Completion

March 16, 2022

Study Completion

March 16, 2023

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)