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

Universitat de Lleida

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT05380726

Moore4Medical

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Experimental group

Experimental group

Description:

A pilot study will be conducted for 2 months with a sample of 10 participants, in order to gather initial data to test the algorithm from the eHealth tool. During the QUAN phase the algorithm will provide individualized feedback and responses to the patients based on their different variables analyzed in real-time by the wrist receiver device: cardiovascular parameters, sleep quality and structure of sleep, physical activity, oxygen saturation. The eHealth tool will contain all the educational materials developed by the researchers of the study. Depending on the information received from the electronic wrist device the eHealth tool will make recommendations of educational topics as hygienic-dietary measures, sleep related habits, or physical activity. The information provided in this regard will be dependent upon the subjects' knowledge gaps/beliefs identified in the QUAL phase and the parameters measures by the electronic wrist device in each subject.

Treatment:

Behavioral: Patient education

Control group

Active Comparator group

Description:

In the control group, the participants will be provided with the same electronic wrist device and access to the eHeatlh tool as the experimental group. However, the electronic wrist device will not provide feedback based on the parameters of each individual. The information provided by the eHealth tool will be general information from the sleep unit of the Arnau de Vilanova - Santa María Hospital instead of the materials developed from the QUAL phase.

Treatment:

Behavioral: Patient education