How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
NCT ID: NCT05056766
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2021-09-01
2022-09-01
Brief Summary
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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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Detailed Description
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Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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single group assignement
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Moderate sleep apnea diagnosis with clinical signs
* Severe sleep apnea with failure continuous positive airway pressure( CPAP)
Exclusion Criteria
* refusal to participate in research
* Patient under guardianship, deprived of liberty, safeguard of justice
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Centre Hospitalier de Valence
OTHER
Responsible Party
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Principal Investigators
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Guillaume BUIRET, MD
Role: PRINCIPAL_INVESTIGATOR
CH VALENCE
Locations
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CH Valence
Valence, , France
Countries
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Other Identifiers
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RIPH-CHV-03
Identifier Type: -
Identifier Source: org_study_id
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