Obstructive Sleep Apnea/Hypopnea SyndromeSAHOSVASNCT05491967
Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome
An observational study of Obstructive Sleep Apnea/Hypopnea Syndrome, run by Centre Hospitalier de Valence at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea/Hypopnea Syndrome
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2021to 16 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis
Who may be able to join
- 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
Who cannot join
- Patient under guardianship, deprived of liberty, safeguard of justice
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- cardiovascular risk
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbimortality vascular criteria
Presence or absence of cardiovascular event
Measured: up to 6 months
morbimortality vascular criteria
Presence or absence of neurologic event
Measured: up to 6 months
morbimortality vascular criteria
Presence or absence of ophthalmologic event
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start16 Mar 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea/Hypopnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491967
- Sponsor's protocol ID
- RIPH-CHV-07
- Acronym
- SAHOSVAS
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05491967
- Acronym / sponsor ID
- SAHOSVAS / RIPH-CHV-07
- Keywords
- cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient under guardianship, deprived of liberty, safeguard of justice
- Refusal to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
morbimortality vascular criteria
Time frame: up to 6 months
Presence or absence of cardiovascular event
morbimortality vascular criteria
Time frame: up to 6 months
Presence or absence of neurologic event
morbimortality vascular criteria
Time frame: up to 6 months
Presence or absence of ophthalmologic event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea/Hypopnea Syndrome, run by Centre Hospitalier de Valence at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbimortality vascular criteria (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.