Wearable Technology in the Detection and Evaluation of Sleep-Related Breathing Disorders (ReSTech)

April 27, 2026 updated by: Patricia Concheiro Moscoso, Universidade da Coruña

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Alvaro Cunqueiro
      • Vigo, Pontevedra, Spain
        • Hospital Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult population with a potential sleep-related breathing disorder.

Description

Inclusion Criteria:

  • Be at least 18 years of age or older.
  • Attend the Sleep Respiratory Disorders and Home Ventilation Unit for the polygraphy test.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nocturnal polygraphy study participants
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.
Device: Xiaomi Mi Smart Band 8
The wearable device, Xiaomi Mi Smart Band 8, will be used solely for observational purposes to assess its accuracy in measuring sleep parameters, oxygen saturation, and heart rate in comparison to nocturnal polygraphy. Participants are receiving routine care as prescribed by their clinicians, and the wearable device is not part of their medical treatment but is being observed alongside standard polygraphy tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording of deep sleep stage
Time Frame: 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.
1 year
Recording of light sleep stage
Time Frame: 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.
1 year
Recording of REM sleep stage
Time Frame: 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.
1 year
Recording of time awake after sleep onset
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracking of step count
Time Frame: 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.
1 year
Tracking of distance
Time Frame: 1 year
The Xiaomi Mi Smart Band 8 device will measure the total distance covered by the participant, recorded in meters.
1 year
Tracking of physical activity duration
Time Frame: 1 year
The Xiaomi Mi Smart Band 8 device will track the total duration of physical activity, recorded in minutes.
1 year
Monitoring of positional changes
Time Frame: 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.
1 year
Monitoring of body movements
Time Frame: 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.
1 year
Recording of heart rate
Time Frame: 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).
1 year
Recording of oxygen saturation
Time Frame: 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).
1 year
Sleep quality and habits measured by a sleep questionnaire
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Collaborators

Center on Information and Communication Technologies
Hospital Álvaro Cunqueiro
NeumoVigo I+i research group
TALIONIS research group

Investigators

  • Principal Investigator: Patricia Concheiro-Moscoso, PhD, CITIC-TALIONIS research group, Universidade da Coruña. Faculty of Health Sciences, Universidade da Coruña.
  • Principal Investigator: Mar Mosteiro-Añon, Physician, Hospital Alvaro Cunqueiro
  • Study Chair: José Alberto Fernández-Villar, PhD, Physician, NeumoVigo I+i. Hospital Álvaro Cunqueiro.
  • Study Chair: Javier Pereira, PhD, CITIC-TALIONIS research group, Universidade da Coruña. Faculty of Health Sciences, Universidade da Coruña.
  • Study Chair: María Luisa Torres-Durán, PhD, Physician, NeumoVigo I+i. Hospital Álvaro Cunqueiro.
  • Study Chair: Betania Groba, PhD, CITIC-TALIONIS research group, Universidade da Coruña. Faculty of Health Sciences, Universidade da Coruña.
  • Study Chair: Manuel Casal-Guisande, PhD, NeumoVigo I+i. Hospital Álvaro Cunqueiro.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Actual)

January 18, 2026

Study Completion (Actual)

January 18, 2026

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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