Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome (EvOPPC)

January 24, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Evaluation of Prognostic Criteria for Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome

Moderate to severe obstructive sleep apnea syndrome (OSAS) (HAI hypopnea apnea index ≥ 15) is a common pathology, which affects 6 to 17% of the general population. The Alaska study, which involved 480,000 apneic patients newly fitted with CPAP, showed that 76.9% of patients were still under treatment for one year, 62.9% after two years, and 52.3% after three years.

All patients who recently diagnosed with OSAS in the Sleep Disorder Unit (unity de Pathologies du Sommeil et de la Vigilance, CHU d'AMIENS-PICARDIE, FRANCE) and who are requiring CPAP will be included. On the day of their hospitalization for the implementation of the CPAP therapy, patients will answer validated questionnaires to assess their level of motivation and adherence to the initiation of treatment but also to assess their knowledge and understanding of the disease and its treatment. These questionnaires will be repeated at the four-month and one-year follow-up consultations (+/- 21 days).

The aim of the study is to identify the prognostic factors of adherence to CPAP, leading to a better understanding and management of patients with sleep apnea syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient (≥ 18 years old)
  • Diagnosis of moderate to severe obstructive sleep apnea syndrome OSAS (AHI ≥ 15) by polygraphy or polysomnography performed in our Sleep disorder Unit
  • Requiring CPAP therapy
  • Informed consent

Exclusion Criteria:

  • Patient previously treated with CPAP therapy
  • Psychiatric illness destabilized
  • Unstable medical condition (i.e. COPD exacerbation, acute cardiac dysfunction, etc.)
  • Planned obesity or ENT surgery (because CPAP treatment is planned for a short period)
  • Central or mixed apnea syndrome
  • Patient under 18 years old
  • Pregnant, parturient or breastfeeding woman
  • Patient under guardianship, curators or deprived of liberty
  • Patient participating in another research including an exclusion period still in progress at the pre-inclusion.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time (in minutes) for the daily use of the CPAP therapy
Time Frame: at 4 weeks
at 4 weeks
Time (in minutes) for the daily use of the CPAP therapy
Time Frame: at 4 months
at 4 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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)

May 5, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2022_843_0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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