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Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

NCT04568408 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2022-05-20

No results posted yet for this study

Summary

Introduction: Polysomnography (PSG) is currently the accepted Gold Standard for sleep studies as it measures multiple variables that lead to a clear diagnosis of any sleep disorder. However, it has some clear drawbacks as it can only be performed by qualified technicians, has a high cost and complexity and is very invasive. In the last years, Actigraphy has been used along with PSG for sleep studies. In this study, the investigators intend to assess the capability of the new Xiaomi Mi Band 5 to be used as a sleep self-assessment tool for patients.

Objective: Determine whether sleep stages recorded by the new Xiaomi Mi Band 5 can effectively replace PSG sleep stages classification in patients that undergo a sleep study.

Methods and analysis: the study will be carried out with patients in a hospital from A Coruña (Galicia, Spain) that are \> 18 years old. Patients who are performed a polysomnography test will be given the wearables so the investigators can record sleep stages with both techniques in order to compare both recordings afterwards.

This is an observational, analytic and longitudinal study. In other words, in this study different variables from the population of interest will be observed and recorded without any direct intervention, so as to establish causality associations between these variables. It is considered as longitudinal since a six-months tracking of the variables will be performed, continually (and sometimes occasionally) recording and monitoring sleep quality (wearable wristbands).

The data obtained from PSG and Xiaomi Mi Band 5 will be preprocessed and explored before extracting the features of interest for the study. Then, Paired sample T-Test will be performed to compare the means among the different variables, Bland-Altman plots will be used to assess the concordance between both techniques and, finally, Epoch by Epoch analysis will be performed to compare the classification of the sleep stages carried out by both PSG and Xiaomi.

Conditions

  • Sleep Disorder

Interventions

DEVICE

Xiaomi MiBand 5

Comparison of sleep-monitoring device against polysomnography (PSG)

Sponsors & Collaborators

  • Center on Information and Communication Technologies

    collaborator OTHER

  • IMQ San Rafael

    collaborator UNKNOWN

  • Universidade da Coruña

    lead OTHER

Principal Investigators

  • Javier Pereira, PhD · Universidade da Coruña

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2020-09-16
Completion
2021-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568408 on ClinicalTrials.gov