CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Xiaomi MiBand 5device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04568408
NCT04568408N/ACompleted

Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

Universidade da Coruña·observational·Posted Sep 29, 2020·Updated May 20, 2022

In Brief

An observational study evaluating Xiaomi MiBand 5 for Sleep Disorder. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disorder
CountriesSpain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 29, 2020
Enrollment StartAug 4, 2020
Primary CompletionSep 16, 2020
Study CompletionDec 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.8 years ago

Interventions

Xiaomi MiBand 5device

Comparison of sleep-monitoring device against polysomnography (PSG)