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Completed

NCT Number: NCT05056766

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

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Valence

Valence, 26953, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. apnea-hypopnea index

    Time frame: 6 months

    severity of sleep apnea

Secondary outcomes

  1. Epworth Sleepiness Scale score

    Time frame: 6 months

  2. pichot fatigue questionnaire

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valence

Other

Collaborators

  • ResMed

Registry information

Official study title

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

Acronym: OAMMM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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