Using eHealth tools to manage obstructive sleep apnea
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
NA · Universitat de Lleida · NCT05380726
This study is testing if using an electronic wristband and a mobile app can help people with obstructive sleep apnea manage their condition better and improve their quality of life over three months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat de Lleida (other) |
| Locations | 1 site (Lleida) |
| Trial ID | NCT05380726 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of eHealth interventions in managing the consequences of obstructive sleep apnea (OSA) and their impact on patients' quality of life over three months. It employs a mixed-method sequential exploratory design, combining qualitative interviews to identify patient beliefs and knowledge gaps with a randomized controlled trial to assess objective and subjective outcomes. Participants will receive an electronic wristband and access to a mobile application that provides tailored recommendations for managing their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate obstructive sleep apnea and diagnosed hypertension who can read and write in Spanish or Catalan.
Not a fit: Patients with a previous diagnosis of obstructive sleep apnea, those currently using CPAP, or individuals unable to manage technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the management and quality of life for patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promise in using technology-based interventions for managing chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lleida
- Biomedical Research Institure of Lleida — Lleida, Spain (RECRUITING)
Study contacts
- Principal investigator: Fran Valenzuela-Pascual, PhD — Biomedical Research Institute of Lleida
- Study coordinator: Oriol o Martínez-Navarro
- Email: omartinez@irblleida.cat
- Phone: 619562618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, obstructive sleep apnoea, eHealth tools, patient education, blood pressure, therapeutic exercise