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

August 28, 2023 updated by: Centre Hospitalier de Valence

How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Valence, France, 26953
        • Ch Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single group assignement
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea-hypopnea index
Time Frame: 6 months
severity of sleep apnea
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Epworth Sleepiness Scale score
Time Frame: 6 months
6 months
pichot fatigue questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Valence

Collaborators

ResMed

Investigators

  • Principal Investigator: Guillaume BUIRET, MD, Ch Valence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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