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

NCT06606691 | Completed

• 1 other identifier: 2024/260
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breathing-Related Sleep Disorder; Sleep Disorder (Disorder)

Keywords

Participatory Health; Internet of Things; Sleep; Polygraphy; Wearable devices; Occupational Performance

Outcome Measures

Primary Outcomes (4)

• Recording of deep sleep stage

  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

  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

  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

  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 Outcomes (8)

• Tracking of step count

  1 year

• Tracking of distance

  1 year

• Tracking of physical activity duration

  1 year

• Monitoring of positional changes

  1 year

• Monitoring of body movements

  1 year

Study Arms (1)

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

Interventions

Xiaomi Mi Smart Band 8 DEVICE

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.

Nocturnal polygraphy study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population with a potential sleep-related breathing disorder.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Center on Information and Communication Technologies: collaborator
• NeumoVigo I+i research group: collaborator
• Hospital Álvaro Cunqueiro: collaborator
• TALIONIS research group: collaborator

Study Sites (2)

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Location

Related Publications (18)

• Lujan MR, Perez-Pozuelo I, Grandner MA. Past, Present, and Future of Multisensory Wearable Technology to Monitor Sleep and Circadian Rhythms. Front Digit Health. 2021 Aug 16;3:721919. doi: 10.3389/fdgth.2021.721919. eCollection 2021.

  PMID: 34713186 BACKGROUND

• de Zambotti M, Cellini N, Goldstone A, Colrain IM, Baker FC. Wearable Sleep Technology in Clinical and Research Settings. Med Sci Sports Exerc. 2019 Jul;51(7):1538-1557. doi: 10.1249/MSS.0000000000001947.

  PMID: 30789439 BACKGROUND

• Gruwez A, Bruyneel AV, Bruyneel M. The validity of two commercially-available sleep trackers and actigraphy for assessment of sleep parameters in obstructive sleep apnea patients. PLoS One. 2019 Jan 9;14(1):e0210569. doi: 10.1371/journal.pone.0210569. eCollection 2019.

  PMID: 30625225 BACKGROUND

• Perez-Pozuelo I, Zhai B, Palotti J, Mall R, Aupetit M, Garcia-Gomez JM, Taheri S, Guan Y, Fernandez-Luque L. The future of sleep health: a data-driven revolution in sleep science and medicine. NPJ Digit Med. 2020 Mar 23;3:42. doi: 10.1038/s41746-020-0244-4. eCollection 2020.

  PMID: 32219183 BACKGROUND

• Espinosa MA, Ponce P, Molina A, Borja V, Torres MG, Rojas M. Advancements in Home-Based Devices for Detecting Obstructive Sleep Apnea: A Comprehensive Study. Sensors (Basel). 2023 Nov 30;23(23):9512. doi: 10.3390/s23239512.

  PMID: 38067885 BACKGROUND

• Teplitzky TB, Zauher AJ, Isaiah A. Alternatives to Polysomnography for the Diagnosis of Pediatric Obstructive Sleep Apnea. Diagnostics (Basel). 2023 Jun 3;13(11):1956. doi: 10.3390/diagnostics13111956.

  PMID: 37296808 BACKGROUND

• Concheiro-Moscoso P, Groba B, Alvarez-Estevez D, Miranda-Duro MDC, Pousada T, Nieto-Riveiro L, Mejuto-Muino FJ, Pereira J. Quality of Sleep Data Validation From the Xiaomi Mi Band 5 Against Polysomnography: Comparison Study. J Med Internet Res. 2023 May 19;25:e42073. doi: 10.2196/42073.

  PMID: 37204853 BACKGROUND

• Hashimoto Y, Sakai R, Ikeda K, Fukui M. Association between sleep disorder and quality of life in patients with type 2 diabetes: a cross-sectional study. BMC Endocr Disord. 2020 Jun 30;20(1):98. doi: 10.1186/s12902-020-00579-4.

  PMID: 32605640 BACKGROUND

• Lyons MM, Bhatt NY, Pack AI, Magalang UJ. Global burden of sleep-disordered breathing and its implications. Respirology. 2020 Jul;25(7):690-702. doi: 10.1111/resp.13838. Epub 2020 May 21.

  PMID: 32436658 BACKGROUND

• Kang JM, Kang SG, Cho SJ, Lee YJ, Lee HJ, Kim JE, Shin SH, Park KH, Kim ST. The quality of life of suspected obstructive sleep apnea patients is related to their subjective sleep quality rather than the apnea-hypopnea index. Sleep Breath. 2017 May;21(2):369-375. doi: 10.1007/s11325-016-1427-8. Epub 2016 Nov 4.

  PMID: 27815846 BACKGROUND

• Chen L, Bai C, Zheng Y, Wei L, Han C, Yuan N, Ji D. The association between sleep architecture, quality of life, and hypertension in patients with obstructive sleep apnea. Sleep Breath. 2023 Mar;27(1):191-203. doi: 10.1007/s11325-022-02589-z. Epub 2022 Mar 23.

  PMID: 35322331 BACKGROUND

• Morsy NE, Farrag NS, Zaki NFW, Badawy AY, Abdelhafez SA, El-Gilany AH, El Shafey MM, Pandi-Perumal SR, Spence DW, BaHammam AS. Obstructive sleep apnea: personal, societal, public health, and legal implications. Rev Environ Health. 2019 Jun 26;34(2):153-169. doi: 10.1515/reveh-2018-0068.

  PMID: 31085749 BACKGROUND

• Borsoi L, Armeni P, Donin G, Costa F, Ferini-Strambi L. The invisible costs of obstructive sleep apnea (OSA): Systematic review and cost-of-illness analysis. PLoS One. 2022 May 20;17(5):e0268677. doi: 10.1371/journal.pone.0268677. eCollection 2022.

  PMID: 35594257 BACKGROUND

• Kaufmann CN, Susukida R, Depp CA. Sleep apnea, psychopathology, and mental health care. Sleep Health. 2017 Aug;3(4):244-249. doi: 10.1016/j.sleh.2017.04.003. Epub 2017 May 26.

  PMID: 28709510 BACKGROUND

• K Pavlova M, Latreille V. Sleep Disorders. Am J Med. 2019 Mar;132(3):292-299. doi: 10.1016/j.amjmed.2018.09.021. Epub 2018 Oct 4.

  PMID: 30292731 BACKGROUND

• Van Ryswyk E, Mukherjee S, Chai-Coetzer CL, Vakulin A, McEvoy RD. Sleep Disorders, Including Sleep Apnea and Hypertension. Am J Hypertens. 2018 Jul 16;31(8):857-864. doi: 10.1093/ajh/hpy082.

  PMID: 29788034 BACKGROUND

• Tester NJ, Foss JJ. Sleep as an Occupational Need. Am J Occup Ther. 2018 Jan/Feb;72(1):7201347010p1-7201347010p4. doi: 10.5014/ajot.2018.020651.

  PMID: 29280728 BACKGROUND

• Concheiro-Moscoso P, Pereira J, Mosteiro-Anon M, Torres-Duran M, Casal-Guisande M, Groba B. ReSTech project on Xiaomi wearable devices for monitoring and detecting obstructive sleep apnoea: observational study protocol. BMJ Open. 2025 Aug 13;15(8):e101824. doi: 10.1136/bmjopen-2025-101824.

  PMID: 40812810 DERIVED

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

• 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 Álvaro Cunqueiro

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research in CITIC-TALIONIS research group, Universidade da Coruña. Faculty of Health Sciences, Universidade da Coruña. PhD in Health Sciences.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 23, 2024
• Study Start: February 18, 2025
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-06

Locations

ES (2)