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

NCT05056766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • ResMed

    collaborator INDUSTRY

  • Centre Hospitalier de Valence

    lead OTHER

Principal Investigators

  • Guillaume BUIRET, MD · CH VALENCE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056766 on ClinicalTrials.gov