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

NCT ID: NCT05369845

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2026-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

questionary

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2022_843_0007

Identifier Type: -

Identifier Source: org_study_id