Wearable Technology in the Detection and Evaluation of Sleep-Related Breathing Disorders
- Conditions
- Breathing-Related Sleep DisorderSleep Disorder (Disorder)
- Interventions
- Device: Xiaomi Mi Smart Band 8
- Registration Number
- NCT06606691
- Lead Sponsor
- Universidade da Coruña
- Brief Summary
This project is an observational study that aims to evaluate the accuracy of wearable devices in detecting potential sleep-related breathing disorders (SRBD) in individuals visiting the Sleep-Related Breathing Disorders and Home Ventilation Unit. The main goal of the study is to determine if wearable devices, like sleep and activity-tracking wristbands and watches, can effectively supplement the detection of these disorders.
The study will analyze various variables related to sleep quality and quantity. Participants will be asked to wear a Xiaomi Mi Band 8 device during an overnight hospital polygraphy test, which will be conducted for one day in their usual daily environment. Additionally, at the beginning of their participation, they will need to complete a questionnaire collecting information about sociodemographic variables, daily habits, routines, and their assessment using the Epworth Sleepiness Scale.
After completing the polygraphy test and using the Xiaomi device, participants will be required to answer another questionnaire addressing aspects related to their sleep quality and habits during this period.
- Detailed Description
In recent years, sleep disorders have gained importance due to their high prevalence and impact on daily life, affecting people\'s ability to perform daily tasks and reducing quality of life. These disorders include difficulties falling asleep, respiratory interruptions, and poor sleep quality, with sleep-related breathing disorders (SRBD), such as obstructive sleep apnea (OSA), being particularly significant. OSA, which involves repeated airway obstructions during sleep, is especially common in older adults, individuals with obesity, and men, but it remains frequently underdiagnosed.
SRBD not only disrupts sleep but also increases the risk of chronic conditions like diabetes, hypertension, and strokes while creating an economic burden due to higher demand for medical resources. Their effects on physical and mental health lead to fatigue, reduced productivity, workplace accidents, and even disability, highlighting the need for more efficient diagnostic and management tools.
While polysomnography (PSG) is the gold standard for diagnosing sleep disorders, its high cost and invasive nature limit its accessibility. Wearable devices, such as wristbands and watches, offer a more accessible and non-invasive alternative, providing real-time data on sleep, heart rate, and activity. Though promising, these devices still require further research to confirm their accuracy in detecting SRBD. This project aims to evaluate the effectiveness of wearables as complementary tools in diagnosing and managing these disorders. Specifically, it has the following specific objectives: (1) To assess the accuracy, specificity, and sensitivity of wearable devices, such as wristbands and watches, in measuring blood oxygen saturation, heart rate, and activity, compared to nocturnal polygraphy. (2) To analyze the effectiveness of these devices in identifying individuals with potential sleep-related breathing disorders (SRBD) using unsupervised learning techniques. (3) To evaluate the impact and performance of an Artificial Intelligence model for detecting and classifying potential SRBD.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 263
- Be at least 18 years of age or older.
- Attend the Sleep Respiratory Disorders and Home Ventilation Unit for the polygraphy test.
- Have significant health complications that hinder active participation in the study.
- Present skin hypersensitivity or a known allergy to the material used in the covers or straps of the wearable devices that will be used as one of the measurement instruments in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nocturnal polygraphy study participants Xiaomi Mi Smart Band 8 This project aims to study approximately 263 individuals from different age groups and genders who are suspected of having sleep-related breathing disorders. The participants will be those referred for a nocturnal polygraphy study at the Sleep-Related Breathing Disorders and Home Ventilation Unit. During the polygraph test, participants will also wear the Xiaomi Mi Smart Band 8 wearable device to compare its accuracy in measuring sleep parameters, oxygen saturation, and heart rate against the polygraphy results.
- Primary Outcome Measures
Name Time Method Recording of deep sleep stage 1 year The Xiaomi Mi Smart Band 8 will record the duration of deep sleep, measured in minutes, to help estimate and identify potential sleep-related breathing disorders.
Recording of light sleep stage 1 year The Xiaomi Mi Smart Band 8 will record the duration of light sleep, measured in minutes, to assist in estimating and detecting potential sleep-related breathing disorders.
Recording of REM sleep stage 1 year The Xiaomi Mi Smart Band 8 will record the duration of the REM sleep stage, measured in minutes, to help estimate and detect potential sleep-related breathing disorders.
Recording of time awake after sleep onset 1 year The Xiaomi Mi Smart Band 8 will record the time spent awake after sleep onset, measured in minutes, to assist in estimating and detecting potential sleep-related breathing disorders.
- Secondary Outcome Measures
Name Time Method Tracking of step count 1 year The Xiaomi Mi Smart Band 8 device will track the total number of steps taken by the participant throughout a 24-hour period. The data will be used to assess physical activity levels and will be recorded as the total step count during the monitoring period.
Tracking of distance 1 year The Xiaomi Mi Smart Band 8 device will measure the total distance covered by the participant, recorded in meters.
Tracking of physical activity duration 1 year The Xiaomi Mi Smart Band 8 device will track the total duration of physical activity, recorded in minutes.
Monitoring of positional changes 1 year The nocturnal polygraph will track changes in body position of participants. This data will help assess physical activity, rest patterns, and potential sleep-related issues. The changes in position will be recorded without a specific unit of measurement.
Monitoring of body movements 1 year The nocturnal polygraph will monitor and record body movements of the participants. These movements will be used to assess physical activity and rest patterns. The data will be recorded without a specific unit of measurement, focusing on the detection of movement occurrence and intensity.
Recording of heart rate 1 year Heart rate monitoring using the Xiaomi Mi Smart Band 8 device and nocturnal polygraph, to compare data from both devices. Both devices record the average heart rate, as well as the maximum and minimum (in BPM).
Recording of oxygen saturation 1 year Oxygen saturation using the Xiaomi Mi Smart Band 8 device and nocturnal polygraph, to compare data from both devices. Both devices record the average oxygen saturation, as well as the maximum and minimum (in percentage).
Sleep quality and habits measured by a sleep questionnaire 1 year This custom-designed questionnaire includes questions related to bedtime and wake-up time, time taken to fall asleep, number of nighttime awakenings, reasons for waking up, perceived sleep quality, pre-sleep activities, and perceived stress levels during the day. It also includes items assessing the quality and quantity of sleep using a 6-point Likert scale, ranging from 0 (strongly disagree) to 5 (strongly agree). The total score ranges from 0 to 45, with higher scores indicating a greater perception of sleep quality and quantity.
Trial Locations
- Locations (1)
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain