Obstructive Sleep Apnea Clinical Trial
— SOCIO-SASOfficial title:
Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.
NCT number | NCT05385302 |
Other study ID # | 38RC21.0367 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 22, 2022 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | July 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHUGA | La Tronche | |
France | Centre du Sommeil de Grenoble | Saint-Martin-d'Hères |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | HP2 Laboratory, ODENORE |
France,
Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-bas — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients | Proportion of CPAP treatment discontinuation without switch to mandibular advancement orthosis treatment | Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion) | |
Secondary | To study the impact of health literacy levels on CPAP refusal after diagnosis. | Proportion of CPAP refusals after diagnosis | At V1 (inclusion) | |
Secondary | To investigate the impact of health literacy levels on adherence status. With adherence status defined here in several ways (=4h vs <4h; adherence quartiles or adherence clusters). | Average CPAP adherence | At 6 month (V2) | |
Secondary | To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment | Average CPAP adherence | At 6 month | |
Secondary | Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy. | Average CPAP adherence | At 6 months | |
Secondary | Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants | Adherent, non-adherent, or discontinued status. With adherence status defined here in several ways (= 4 hours per night for at least 70% of the nights ; adherence quartiles or adherence clusters). | At 6 months | |
Secondary | Determine adherence trajectories as a function of health literacy and specifically study the specific determinants of adherence. | Daily CPAP adherence data obtained by telemonitoring | Over 6 months | |
Secondary | To decipher the links made by people in treatment discontinuation or qualified as non-observant from the medical point of view, between the different factors of non-observance identified. | Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence. | within 15 days of refusal of CPAP treatment, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for both non-adherent and adherent patients at 6 months. | |
Secondary | Understand how people explain these situations based on their life contexts, representations of the disease and treatment, particularly their understanding of the issues involved. | Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence. | Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment for patients who stopped treatment during the 6-month follow-up, or within 15 days of visit 2 for non-adherent patients at 6 month | |
Secondary | Analyze people's perceptions of their health information practices, their relationship with the medical profession and the role of those involved in their pathology to understanding CPAP treatment | Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence. | Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for all patients at 6 month | |
Secondary | Identify the change in adherent patient's relationship to their treatment and the perceived benefits | Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' adherence. | Within 6 months of the first interview | |
Secondary | Describe the evolution of non-adherent patient's situation, the health and potential compensation strategies or alternatives that they have implemented to limit the impact of their untreated OSAS | Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence. | Within 6 months of the first interview for non-adherent patients |
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