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

NCT05369845 | Active Not Recruiting

• 1 other identifier: PI2022_843_0007
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  at 4 weeks

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

  at 4 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: May 5, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)