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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of an E-health Intervention on Blood Pressure, Sleep Quality and Physical Activity in Patients With Obstructive Sleep Apnoea: A Sequential Exploratory Mixed-method Research Protocol With a Realist Evaluation Approach

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Patient education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: We will carry out a mixed-method exploratory sequential investigation with a realistic evaluation approach. The use of this mixed methodology allows us to use the strengths of the qualitative and quantitative phases while reducing their weaknesses. Specifically, the sequential exploratory design includes an initial qualitative phase followed by a quantitative phase, with the aim of developing an educational tool. In this project it is proposed that both phases should have the same relevance (QUAL-QUAN) for the development of the educational tool and the development of the study should be carried out in three stages. During all phases of the project, the realistic evaluation approach will be taken into account, especially after the intervention, carrying out different semi-structured interviews and focus groups to redefine the cycle and optimize future research.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Behavioral: Patient education<br>* The intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time. The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity.<br>* Other names: physical activity;|
| Active Comparator: Control group<br>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. | Behavioral: Patient education<br>* The intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time. The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity.<br>* Other names: physical activity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure: Blood pressure changes after 3 months of intervention, measured with a holter blood pressure recorder (Spacelabs 90217A, Hertford: UK). | Pre-post (after 3 months of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysgraphy | Twe will use respiratory polygraphy (Embletta, ResMed, Bella Vista, NSW, Australia) to assess the AHI, oxygen desaturation index (ODI, >4%), minimum and mean oxygen saturation (SaO2), the average duration of events and percentage of time with SaO2 <90%. | Pre-post (after 3 months of intervention) | 
| The Pittsburgh Sleep Quality Inventory (PSQI) | ) is a 19-item list of items used to measure sleep quality and disturbances over the past month. As part of the PSQI, various sleep characteristics are measured, including sleep latency (i.e., the amount of time taken to fall asleep). On a scale of 0 to 3, each item is scored (0 = not during the past month; 1 = less than once a week; 2 = once or twice a week; and 3 = three or more times a week) (49). These scores are summed to generate an overall score. The higher the scores, the lower the quality of sleep. A score of more than five indicates poor sleep quality. With an alpha value of 0.83, the PSQI has demonstrated reliability in its internal consistency | Pre-post (after 3 months of intervention) | 
| Daytime sleepiness assessment | Subjective sleepiness will be assessed using the Epworth Sleepiness Scale (ESS) validated in Spanish. This is a questionnaire that contains eight items that indicate the probability of falling asleep during activities of daily living, ranging from 0 (never) to 3 (high probability). Normal values will be established between 2 and 10, with values greater than 10 indicating daytime sleepiness | Pre-post (after 3 months of intervention) | 
| Six-minute walk test (6MWT) | The 6MWT test evaluates the respiratory, cardiovascular, metabolic, musculoskeletal, and sensorineural responses to exercise. It is considered a useful tool for assessing the functional capacity of patients with chronic respiratory and/or cardiovascular diseases and is used to assess the submaximal level of functional performance at a similar level required for daily physical activities (55). 6MWT measures the maximum distance an individual is able to walk as fast as possible (not run) using their usual walking aids if any, and take their regular medications before the test, in 6 minutes. The patients can rest is allowed as required but the time is not stopped. The 6MWT is normally carried out in a corridor of 30 meters in length, on a hard and flat surface, and preferably indoors | Pre-post (after 3 months of intervention) | 
| Empowerment and motivation for change | The Spanish version of the Health Empowerment Scale will be used to measure empowerment, while motivation will be measured using the Self-Efficacy Scale for Physical Activity | Pre-post (after 3 months of intervention) | 
| Health-related quality of life | This will be assessed using the EuroQol-5D (EQ-5D) questionnaire in its valid Spanish version | Pre-post (after 3 months of intervention) | 
| Anthropometry measurement 1 | Body mass index (BMI) (kg / m 2). In order to calculate BMI, Weight (kg) and height (m) will be measured using a scale and a standard stadiometer. | Pre-post (after 3 months of intervention) | 
| Anthropometry measurements 2 | Waist-to-hip ratio. The waist, and hip circumferences, measured in triplicate and averaged, will be taken into consideration. | Pre-post (after 3 months of intervention) | 
| Adherence to the program/treatment | Scale of adherence and number of entries to the telephone application. | Post intervention (after 3 months) | 
| Cost-benefit | Comparison through the final costs of the current project and the studied costs of conservative treatment according to the research by Tarraubella et al. (2018) | Post intervention (after 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnoea, eHealth tools, patient education, blood pressure, therapeutic exercise