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

NCT05380726 | Recruiting

• 1 other identifier: Moore4Medical
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnoea; eHealth tools; patient education; blood pressure; therapeutic exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Polysgraphy

  Pre-post (after 3 months of intervention)

• The Pittsburgh Sleep Quality Inventory (PSQI)

  Pre-post (after 3 months of intervention)

• Daytime sleepiness assessment

  Pre-post (after 3 months of intervention)

• Six-minute walk test (6MWT)

  Pre-post (after 3 months of intervention)

• Empowerment and motivation for change

  Pre-post (after 3 months of intervention)

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Patient education BEHAVIORAL

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.

Also known as: hygienic-dietary measures, sleep related habits, physical activity

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• Institut de Recerca Biomèdica de Lleida: collaborator
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Biomedical Research Institure of Lleida

Lleida, 25198, Spain

RECRUITING

Related Publications (1)

• Valenzuela-Pascual F, Verdejo-Amengual FJ, Martinez-Navarro O, Blanco-Blanco J, El Arab RA, Rubinat-Arnaldo E, Masbernat-Almenara M, Rubi-Carnacea F, Manuel Marti B, Barbe F, Sanchez-de-la-Torre M. 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. BMJ Open Respir Res. 2024 Dec 18;11(1):e001889. doi: 10.1136/bmjresp-2023-001889.

  PMID: 39694678 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Patient Education as Topic; Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fran Valenzuela-Pascual, PhD

  Biomedical Research Institute of Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriol o Martínez-Navarro

CONTACT

619562618; omartinez@irblleida.cat

Fran Valenzuela-Pascual

CONTACT

fran.valenzuela@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study will be triple-blind since, due to its nature (intervention using an eHealth tool), it will be possible to blind both the participants, researchers and statisticians. All the subjects (experimental and control) will receive the same electronic wrist device and eHealth tool. While experimental group receive specific information related to the parameters assessed in real time by the wrist device, the control group will receive general information about obstructive sleep apnoea.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: May 19, 2022
• Study Start: September 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)