Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome (EvOPPC)
Primary Purpose
Obstructive Sleep Apnea Syndrome, Continuous Positive Airway Pressure, Adherence
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionary
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, Continuous Positive Airway Pressure, Adherence, Perception and Beliefs
Eligibility Criteria
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, curatorship or deprived of liberty
- Patient participating in another research including an exclusion period still in progress at the pre-inclusion.
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
Time (in minutes) for the daily use of the CPAP therapy
Time (in minutes) for the daily use of the CPAP therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT05369845
First Posted
May 6, 2022
Last Updated
January 24, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05369845
Brief Title
Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
Acronym
EvOPPC
Official Title
Evaluation of Prognostic Criteria for Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Continuous Positive Airway Pressure, Adherence, Perception and Beliefs
Keywords
Obstructive Sleep Apnea Syndrome, Continuous Positive Airway Pressure, Adherence, Perception and Beliefs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
questionary
Intervention Description
the patient will complete validated questionnaires, at three periods (at the time of the initiation of the CPAP, and during the 2 planned follow-up consultations: four months and at 1 year) The validated questionnaires are as follows: Illness Perception Questionnaire (IPQ-R), Beliefs about Medicines Questionnaire (BMQ), Morisky Medication Adherence Scale (MMAS), Hospital Anxiety and Depression Scale (HADS), Rollnick Scale.
Primary Outcome Measure Information:
Title
Time (in minutes) for the daily use of the CPAP therapy
Time Frame
at 4 weeks
Title
Time (in minutes) for the daily use of the CPAP therapy
Time Frame
at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie BASILLE-FANTINATO, MD
Phone
03 22 45 59 61
Email
basille.Aurelie@CHU-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Basille-Fantinato, MD
Phone
+330322455961
Email
basille.aurelie@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
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