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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380726
• Other study ID #: Moore4Medical
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: Universitat de Lleida
• Contact: Oriol o Martínez-Navarro
• Phone: 619562618
• Email: omartinez[@]irblleida.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Patient education
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.

Locations

Country	Name	City	State
Spain	Biomedical Research Institure of Lleida	Lleida

Sponsors (3)

Lead Sponsor	Collaborator
Universitat de Lleida	Horizon 2020 - European Commission, Institut de Recerca Biomèdica de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Adherence to the program/treatment	Scale of adherence and number of entries to the telephone application.	Post intervention (after 3 months)
Secondary	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)