Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol

• Published in: BMJ open respiratory research 2024-12, Vol.11 (1), p.e001889
• Main Authors: Valenzuela-Pascual, Fran, Verdejo-Amengual, Francisco Jose, Martinez-Navarro, Oriol, Blanco-Blanco, Joan, El Arab, Rabie Adel, Rubinat-Arnaldo, Esther, Masbernat-Almenara, Maria, Rubí‑Carnacea, Francesc, Manuel Martí, Blanca, Barbé, Ferran, Sanchez-de-la-Torre, Manuel
• Format: Article
• Language: English
• Subjects: Adult; Algorithms; Antihypertensives; Blood pressure; Blood Pressure - physiology; Body mass index; Cardiovascular disease; Continuous positive airway pressure; Deep learning; Exercise; Female; Health care; Heart failure; Humans; Hypertension; Hypertension - therapy; Intervention; Male; Mobile Applications; Patient education; Physical fitness; Pilot projects; Prevention; Protocol; Public health; Quality of Life; Randomized Controlled Trials as Topic; Restless legs syndrome; Sleep; Sleep apnea; Sleep Apnea, Obstructive - therapy; Sleep apnoea; Sleep Quality; Telemedicine
• ISSN: 2052-4439; 2052-4439
• DOI: 10.1136/bmjresp-2023-001889

IntroductionThe management of a chronic and frequent pathology, such as obstructive sleep apnoea (OSA), requires personalised programmes that implement new technology-based tools to improve the comprehensive treatment of the patient to reduce the morbidity associated with this disease. This study will evaluate the effectiveness of an eHealth tool in managing the pathophysiological consequences of OSA and how they impact the quality of life after 3 months of intervention among adults.Methods and analysisThis is a mixed-method sequential exploratory study protocol. Participants will be≥18 years with a new diagnosis of moderate OSA and diagnosed with hypertension. The qualitative phase will consist of personal semistructured interviews. The quantitative phase will be a triple-blind randomised controlled trial. The experimental group (n=135) will receive an eHealth intervention using an electronic wrist device and a mobile application that will offer specific healthcare recommendations, physical activity indications and hygienic and dietary advice. These recommendations will be based on the information obtained in the qualitative phase. Those in the control group (n=135) will receive the usual educational materials from the sleep unit. The primary outcome will be blood pressure changes at 3 months. Secondary outcomes are subjective sleep quality, sleep apnoea-related parameters, daytime sleepiness, physical activity, empowerment and motivation for change, quality of life, anthropometry, cost–benefit and adherence.Ethics and disseminationEthical approval for the study has been obtained from the Hospital Universitari Arnau de Vilanova (CEIC-2511). Results will be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Identifier: NCT05380726.