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

Not Applicable

Recruiting

• Conditions: Continuous Positive Airway Pressure; Perception and Beliefs; Obstructive Sleep Apnea Syndrome; Adherence

• Registration Number: NCT05369845
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-05
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2024-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time (in minutes) for the daily use of the CPAP therapy	at 4 months

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France