Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

NCT04568408 | Completed

• 1 other identifier: 2020/318
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

Sleep; Polysomnography; Occupational Performance; Participatory Health; Internet of Things; Wearables

Outcome Measures

Primary Outcomes (1)

• Sleep recording Reliability

  Assessment of sleep measurement and sleep stages classification

  6 Months

Study Arms (1)

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

Interventions

Xiaomi MiBand 5 DEVICE

Comparison of sleep-monitoring device against polysomnography (PSG)

Sleep study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population with a self-perception of sleep problems or poor quality of their sleep

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade da Coruña: lead
• Center on Information and Communication Technologies: collaborator
• IMQ San Rafael: collaborator

Study Sites (1)

Universidade da Coruña

A Coruña, 15006, Spain

Location

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MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Javier Pereira, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor PhD

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 29, 2020
• Study Start: August 4, 2020
• Primary Completion: September 16, 2020
• Study Completion: December 30, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

ES (1)