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

Centre Hospitalier de Valence

Status: Completed

Conditions: Sleep Apnea Syndromes; Respiratory Tract Diseases; Sleep Apnea, Obstructive

Treatments: Behavioral: questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05056766

00002

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

20 participants in 1 patient group

single group assignement

Treatment:

Behavioral: questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.