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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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