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

Obstructive Sleep Apnea Syndrome Clinical Trial

— EvOPPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369845
• Other study ID #: PI2022_843_0007
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Aurélie BASILLE-FANTINATO, MD
• Phone: 03 22 45 59 61
• Email: basille.Aurelie[@]CHU-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence
• Apnea
• Continuous Positive Airway Pressure
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in minutes) for the daily use of the CPAP therapy		at 4 weeks
Primary	Time (in minutes) for the daily use of the CPAP therapy		at 4 months