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

C

Centre Hospitalier Universitaire, Amiens

Status

Active, not recruiting

Conditions

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

Treatments

Other: questionary

Study type

Interventional

Funder types

Other

Identifiers

NCT05369845
PI2022_843_0007

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Aurélie BASILLE-FANTINATO, MD

Data sourced from clinicaltrials.gov

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