Sleep Apnea SyndromesOAMMMNCT05056766
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
An observational study of Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by Centre Hospitalier de Valence at 1 site in France.
Trial summary
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases
- What is being tested?
- questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Sep 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).
Who may be able to join
- Age ≥ 18 years old
- Moderate sleep apnea diagnosis with clinical signs
- Severe sleep apnea with failure continuous positive airway pressure( CPAP)
Who cannot join
- previous sleep apnea treatment for Moderate sleep apnea
- refusal to participate in research
- Patient under guardianship, deprived of liberty, safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
Read the detailed description
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
- Being tested
- questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.
- Keywords
- oral appliance
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.Behavioural
Each patient will undergo 3 to 7 polygraphy recordings according usual practice of titration At the same time, Self-questionnaires will be conducted by the patient in order to evaluate Oral appliance efficacy.
Optimal titration of oral appliance will be done according subjectives parameters. (sleepeness Reduction and fatigue Reduction).
Neither the investigator nor the patient will know the polygraphy results (apnea-hypopnea index)
| Study group | Role | What they receive |
|---|---|---|
| single group assignement | Not described Receives: Behavioral: questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
severity of sleep apnea
Measured: 6 months
Secondary outcomes (2)
Epworth Sleepiness Scale score
Measured: 6 months
pichot fatigue questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Sponsor
- Investigators
- Guillaume BUIRET, MD, Principal investigator, CH VALENCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056766
- Sponsor's protocol ID
- RIPH-CHV-03
- Acronym
- OAMMM
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2021
- 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
- How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"
- ClinicalTrials.gov ID
- NCT05056766
- Acronym / sponsor ID
- OAMMM / RIPH-CHV-03
- Keywords
- oral appliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 27 Sep 2021 (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.
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
Detailed description
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group assignement | – | Behavioral: questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Moderate sleep apnea diagnosis with clinical signs
- Severe sleep apnea with failure continuous positive airway pressure( CPAP)
Key exclusion criteria (3 listed)
- previous sleep apnea treatment for Moderate sleep apnea
- refusal to participate in research
- Patient under guardianship, deprived of liberty, safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.Each patient will undergo 3 to 7 polygraphy recordings according usual practice of titration At the same time, Self-questionnaires will be conducted by the patient in order to evaluate Oral appliance efficacy. Optimal titration of oral appliance will be done according subjectives parameters. (sleepeness Reduction and fatigue Reduction). Neither the investigator nor the patient will know the polygraphy results (apnea-hypopnea index) | Behavioural | single group assignement |
Primary outcome
apnea-hypopnea index
Time frame: 6 months
severity of sleep apnea
2 secondary outcomes
Epworth Sleepiness Scale score
Time frame: 6 months
pichot fatigue questionnaire
Time frame: 6 months
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.
Guillaume BUIRET, MD principal investigator
CH VALENCE
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 Sleep Apnea Syndromes and Sleep Apnea, Obstructive, 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 3 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?
apnea-hypopnea index (time frame: 6 months). 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.