NCT05056766

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
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier de Valence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	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)

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-09-27
• Last updated: 2025-09-08

Locations

1 site across 1 country: France