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NCT Number: NCT05369845

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionary

Other

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 outcomes

  1. Time (in minutes) for the daily use of the CPAP therapy

    Time frame: at 4 weeks

  2. Time (in minutes) for the daily use of the CPAP therapy

    Time frame: at 4 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: EvOPPC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 11, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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