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Clinical Trials in France / NCT05369845
Active, not recruiting Not applicable

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

NCT05369845 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-05-05
Last updated
2025-05-28

Condition(s) studied

Obstructive Sleep Apnea SyndromeContinuous Positive Airway PressureAdherencePerception and Beliefs

Investigational drug(s) / intervention(s)

questionary

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France

More Centre Hospitalier Universitaire, Amiens trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05369845 on ClinicalTrials.gov ↗ ← All trials in France