Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients

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Description

Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.

Study Overview

Start Date
September 22, 2022
Completion Date
July 1, 2025
Enrollment
250
Date Posted
May 23, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
CHUGA
La Tronche 38043, France

Centre du Sommeil de Grenoble
Saint-Martin-d'Hères, France

Eligibility

Study Population
Obstructive Sleep Apnea patients with cPAP indication
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Patient newly diagnosed with OSA
Patient with indication for CPAP
Voluntary patient with informed consent and no objection to participation
Patient affiliated with or benefiting from a social security plan

Non-Inclusion Criteria:

Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curators) according to articles L1121-5 to L1121-8
Refusal of participation by the patient
Patient refusing telemonitoring

Study Contact Info

Study Contact Name
Sébastien Bailly, PharmD, PhD; Andry Rakotovao, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Obstructive sleep apnea syndrome (OSA) is a chronic multi-organ pathology and heterogeneous in its presentation and phenotypes.

To date, continuous positive airway pressure (CPAP) is the first-line treatment for OSA. In France, 1.2 million patients are treated with CPAP but 15% of patients refused the device at the time of diagnosis and the rate of non-adherence reach 43% 3 years after CPAP initiation.

Both in terms of sleepiness and cardiovascular symptoms, clinical improvement is correlated with normalization of ventilation and therefore with the use of CPAP throughout the sleep period by the patients. Adherence to CPAP is nowadays achieved by the contribution of tele-observance, which provides prescribers, home health care providers and patients with daily feedback on the effectiveness and compliance of the therapy.

To date, studies targeting the predictive factors of CPAP compliance in OSA patients mainly include clinical data (age, sex, severity of OSAS, symptoms, etc.), or technical factors directly related to CPAP treatment (type of mask, residual apnea hypopnea index (AHI) under treatment, leakage, side effects, etc.).

The social, socioeconomic and psychological approaches are far less studied and frankly underestimated, although they are gradually gaining interest, representing the submerged part of the iceberg. Some studies have shown an association between poor socioeconomic status and poor compliance with CPAP, while others have focused on psychological factors. Finally, in the work of our team, we have recently looked at the impact of the marital on compliance and the perception of the associated benefit. However, each study targets a specific area, without taking into account the clinical and individual determinants. Therefore, there is a lack of knowledge about individual determinants of CPAP adherence.

Health literacy, defined as "the ability to access, understand, evaluate, and communicate information in ways that promote, maintain, and improve one's health in a variety of settings across the lifespan" is a possible important limitation for a patient to understand the need for PAP treatment and was never explored in view to explain CPAP adherence.

This project aims to exploit a unique transdisciplinary approach to characterize refusal, discontinuation, and nonadherence to CPAP in patients with diagnosed OSA newly managed on CPAP.

The main hypothesis of the study is that a patient with an insufficient level of health literacy (LS) (score from 0 to 8 defined from the European Health Literacy Survey questionnaire) has a greater probability of stopping treatment early or of being non-compliant than a patient with better performance in terms of health literacy.
NCTid (if applicable)
NCT05385302