ReSTech project on Xiaomi wearable devices for monitoring and detecting obstructive sleep apnoea: observational study protocol

Abstract

Introduction: Sleep-related breathing disorders have become a significant public health concern due to their negative impact on the population's quality of life and overall health. Despite being underdiagnosed, their prevalence has increased in recent years, particularly in cases of obstructive sleep apnoea (OSA). Early diagnosis and detection of OSA are essential for timely treatment to mitigate the physical and health consequences. While polysomnography remains the gold standard for diagnosis, its limitations have led to the adoption of nocturnal polygraphy as an alternative for diagnosis. The scientific community is seeking devices that enable continuous monitoring of sleep status and other relevant parameters in this population. This study aims to analyse a wearable device as a complementary tool for monitoring health status and daily activity in people with potential OSA.

Methods and analysis: This observational and cross-sectional study will be conducted at the Sleep Respiratory Disorders and Home Ventilation Unit of a Hospital Álvaro Cunqueiro in Vigo. The aim is to recruit 246 participants who meet the inclusion criteria. Specific statistical methods will be employed to evaluate the accuracy and quality of the data collected by the Xiaomi Mi Smart Band 9.

Ethics and dissemination: This protocol study has been approved by the Pontevedra-Vigo Ourense Research Ethics Committee (process number 2024/260). All participants will sign a statement of informed consent. Study results will be disseminated in peer-reviewed journal articles.

Trial registration number: NCT06606691.

Keywords: Health; Health informatics; Quality of Life; eHealth.

Figure 1. Design of the study.

Figure 2. Wearable device synchronisation process. SFTP, Secure File Transfer Protocol.