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Effectiveness of an E-health Intervention in Patients With Obstructive Sleep Apnoea

Recruiting
18 years of age
Both
Phase N/A

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Overview

Obstructive sleep apnoea is a highly burdensome condition that not only impairs function but also confers a risk of cardiovascular disease. This is particularly evident among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the management of a chronic and frequent pathology such as OSA, it is necessary to have personalized programs that implement new technology-based tools to improve the comprehensive management of the patient in order to reduce the morbidity associated with this disease.

Description

Objectives: The purpose of this study is to evaluate the effectiveness of eHealth tools in managing obstructive sleep apnoea pathophysiological consequences and how they impact the quality of life after 3 months of intervention in adults.Qual:To identify OSA patients' beliefs concerning their condition and its treatment. Connection: To construct the information resources that the mobile application will offer using the QUAL results. Quan: Objective sleep parameters, Subjective sleep quality , Daytime sleepiness Physical activity habits, Quality of life related to health, Self-efficacy and empowerment, Anthropometry, Adherence to the program/treatment, Cost / benefit.

Design: Mixed-method sequential exploratory design with realist evaluation approach.

Population and sample: Patients referred to the sleep unit of the Arnau de Vilanova - Santa María Hospital for a suspected diagnosis of obstructive sleep apnoea. For the qualitative phase, the subjects will be contacted and invited to participate in a semi-structured personal interview related to the gaps and knowledge needs that these types of patients have about the pathology itself and its management. The quantitative phase will be a randomized controlled trial. Subjects will be randomly assigned using a simple random technique. The experimental group will receive an eHealth intervention through an electronic wristband device and access to the eHealth tool (phone application) that will offer specific recommendations on health, physical activity and hygienic-dietary advice. All these recommendations will be based on the information obtained in the qualitative phase and the parameters mesured by the electronic wristband device in real time. Those in the control group will receive the same electronic wristband device and the same access to the ehealth tool, but the information received will be based on the general hygienic-dietary measures that the sleep unit provides to all patients.

This research belongs to Moore4Medical project. It has received funding within the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU) in collaboration with the European Union's H2020 Framework Programme (H2020/2014-2020) and National Authorities, under grant agreement H2020-ECSEL-2019-IA-876190.

Eligibility

Inclusion Criteria:

  • Moderate OSA (apnoea-hypoapnoea index (AHI)) of 15-30
  • Hypertension diagnosed by 24h-ABPM
  • Men and women aged ≥ 18 years
  • Spanish and/or Catalan can be read, written, and spoken
  • Currently residing in Lleida (Spain)
  • Own or have access to mobile phone (Android and IOS)

Exclusion Criteria:

  • Previous diagnosis of OSA / use of CPAP
  • Pregnancy
  • Body mass index (BMI) below 17
  • Subjects undergoing bariatric intervention or on the waiting list for it
  • Not being able to fill out questionnaires
  • Incapacity to handle technology

Study details

Obstructive Sleep Apnea

NCT05380726

Universitat de Lleida

14 May 2024

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