How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement

How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05056766

Acronym

OAMMM

Enrollment

Registered

2021-09-27

Start date

2021-09-01

Completion date

2022-09-01

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Diseases, Sleep Apnea, Obstructive, Sleep Apnea Syndromes

Keywords

oral appliance

Brief 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). 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

Interventions

BEHAVIORALquestionnaires: 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)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years old * Moderate sleep apnea diagnosis with clinical signs * Severe sleep apnea with failure continuous positive airway pressure( CPAP)

Exclusion criteria

* previous sleep apnea treatment for Moderate sleep apnea * refusal to participate in research * Patient under guardianship, deprived of liberty, safeguard of justice

Design outcomes

Primary

Measure	Time frame	Description
apnea-hypopnea index	6 months	severity of sleep apnea

Secondary

Measure	Time frame
Epworth Sleepiness Scale score	6 months
pichot fatigue questionnaire	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026