Obstructive Sleep Apnea Syndrome Clinical Trial
— EvOPPCOfficial title:
Evaluation of Prognostic Criteria for Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
NCT number | NCT05369845 |
Other study ID # | PI2022_843_0007 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2022 |
Est. completion date | May 2025 |
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.
Status | Recruiting |
Enrollment | 132 |
Est. completion date | May 2025 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time (in minutes) for the daily use of the CPAP therapy | at 4 weeks | ||
Primary | Time (in minutes) for the daily use of the CPAP therapy | at 4 months |
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