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NCT05056766 Clinical Trial

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

Sleep Apnea, Obstructive Clinical Trial

— OAMMM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05056766
Other study ID # 00002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2022

Study information
Verified date August 2023
Source Centre Hospitalier de Valence
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
France CH Valence Valence

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier de Valence ResMed

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary apnea-hypopnea index severity of sleep apnea 6 months
Secondary Epworth Sleepiness Scale score 6 months
Secondary pichot fatigue questionnaire 6 months
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