Researchers have launched a mixed-method sequential exploratory study to evaluate whether an eHealth intervention can help manage blood pressure and other health parameters in patients with moderate obstructive sleep apnea, according to a protocol.
The Moore4Medical trial will assess whether a wrist device paired with a mobile application providing personalized health care recommendations can impact blood pressure, sleep quality, and physical activity levels in adults with moderate obstructive sleep apnea (OSA) and hypertension over a 3-month period.
"The management of a chronic and frequent pathology, such as [OSA], requires personalized programs that implement new technology-based tools to improve the comprehensive treatment of the patient to reduce the morbidity associated with this disease," the study authors wrote in BMJ Open Respiratory Research.
The triple-blind randomized controlled trial will include 270 participants aged 18 and older with newly diagnosed moderate OSA (AHI 15 to 30) and hypertension. The experimental group (n = 135) will receive specific health care recommendations through the eHealth tool based on real-time physiological data collected by the wrist device. The control group (n = 135) will receive standard educational materials from their sleep unit.
The study's primary outcome measure will be changes in 24-hour ambulatory blood pressure monitoring at 3 months. Secondary outcomes will include:
- Subjective sleep quality measured by the Pittsburgh Sleep Quality Index
- Sleep apnea parameters via respiratory polygraphy
- Daytime sleepiness assessed by the Epworth Sleepiness Scale
- Physical activity levels via 6-minute walk test
- Quality-of-life metrics
- Treatment adherence
- Cost-benefit analysis.
Prior to the randomized trial, the researchers will conduct qualitative interviews with patients who have OSA to inform the development of the educational content delivered through the mobile application.
The researchers noted that the study is among one of "the first triple-blind clinical trials addressing the patient education management of [those] with moderate OSA not being treated with CPAP [continuous positive airway pressure]."
This approach could provide "a cost-effective and noninvasive way to promote healthy lifestyles and manage moderate OSA without CPAP," according to the protocol.
The study is part of Moore4Medical, a multicenter international project funded through the European Union's H2020 Framework Programme. The results are expected to be published in a peer-reviewed journal.
Important limitations of the study may include potential challenges with technology adoption among participants and difficulty ensuring patients fully comprehend and integrate the educational materials provided through the app.
The trial has been registered at ClinicalTrials.gov (NCT05380726) and received ethical approval from the Hospital Universitari Arnau de Vilanova (CEIC-2511).
The combination of quantitative and qualitative methodologies may provide valuable insights into both the effectiveness of eHealth interventions for OSA management as well as patient perspectives on using such technology-based approaches for chronic disease self management.
The authors declared having no competing interests.
