Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients — SOCIO-SAS  

Obstructive Sleep Apnea Clinical Trial

Official title: Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adherence, Treatment
• Apnea
• Health Literacy
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT05385302
• Study type: Observational
• Source: University Hospital, Grenoble
• Contact: Sébastien Bailly, PharmD, PhD
• Phone: +33 476 766 918
• Email: sbailly@chu-grenoble.fr
• Status: Recruiting
• Start date: September 22, 2022
• Completion date: July 2025