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

NCT05056766 | Completed

• 1 other identifier: RIPH-CHV-03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

oral appliance

Outcome Measures

Primary Outcomes (1)

• apnea-hypopnea index

  severity of sleep apnea

  6 months

Secondary Outcomes (2)

• Epworth Sleepiness Scale score

  6 months

• pichot fatigue questionnaire

  6 months

Study Arms (1)

single group assignement

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

Interventions

questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire. BEHAVIORAL

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)

single group assignement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Valence: lead
• ResMed: collaborator

Study Sites (1)

CH Valence

Valence, 26953, France

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Guillaume BUIRET, MD

  CH VALENCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

FR (1)