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Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568408
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : May 20, 2022
Sponsor:
Collaborators:
Center on Information and Communication Technologies
IMQ San Rafael
Information provided by (Responsible Party):
Javier Pereira, Universidade da Coruña

Brief 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.


Condition or disease Intervention/treatment
Sleep Disorder Device: Xiaomi MiBand 5

Detailed Description:

Introduction: Sleep disorders are becoming a widespread health problem within the general population. Beyond the tiredness itself, these disorders have been found to be related to physical and mental issues like cardiovascular pathologies, obesity, depression and anxiety. This makes clear the necessity of achieving a quality rest to prevent potential chronic diseases. On this issue, 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, several studies that focus on validating wearable devices as useful sleep trackers have emerged. In this study, the investigators intend to assess the capability of the new Xiaomi Mi Band 5 to be used as a tool for sleep self-assessment for patients. The interest in studying this smartband is due to its low price and acceptance among the population. If this device proves to be a good sleep tracker, it would allow the population to assess their own sleep and consider if they need to visit their medical practitioner, which would improve the prognosis of any underlying condition they may be developing derived from their restlessness.

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. The following features will be calculated for both devices: total sleep time, sleep efficiency, sleep latency and wake after sleep onset. Sleep stages will also be recorded.

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands
Actual Study Start Date : August 4, 2020
Actual Primary Completion Date : September 16, 2020
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pet Health

Group/Cohort Intervention/treatment
Sleep study participants
Adults presenting sleep difficulties or poor sleep quality that are performed a Polisomnography study in a Sleep Unit at hospital.
Device: Xiaomi MiBand 5
Comparison of sleep-monitoring device against polysomnography (PSG)




Primary Outcome Measures :
  1. Sleep recording Reliability [ Time Frame: 6 Months ]
    Assessment of sleep measurement and sleep stages classification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult population with a self-perception of sleep problems or poor quality of their sleep
Criteria

Inclusion Criteria:

  • Attending to the Sleep Unit to be perfomed a Polysomnography study
  • Declaring a chronological age that is equal or higher than 18 years old

Exclusion Criteria:

  • Having significant health complications that hinder active participation in the study
  • Suffering from skin hypersensitivity or an allergic reaction due to the materials the wristbands that will be used in the study as measuring instruments are made of

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568408


Locations
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Spain
Universidade da Coruña
A Coruña, Spain, 15006
Sponsors and Collaborators
Universidade da Coruña
Center on Information and Communication Technologies
IMQ San Rafael
Investigators
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Principal Investigator: Javier Pereira, PhD Universidade da Coruña
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javier Pereira, Proffesor PhD, Universidade da Coruña
ClinicalTrials.gov Identifier: NCT04568408    
Other Study ID Numbers: 2020/318
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Pereira, Universidade da Coruña:
Sleep
Polysomnography
Occupational Performance
Participatory Health
Internet of Things
Wearables
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders