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Sponsor study identifier
observational
21
1 country
1
Study Start
December 19, 2018
Actual (reported)Primary Completion
December 19, 2019
Actual (reported)Study Completion
December 19, 2019
Actual (reported)Introduction: Poor sleep quality is common in most older adults. Because of the progressive aging of the population in Spain, there are more and more nursing-home and day centers, which give care to older adults. However, the attention focused on some difficulty related to sleep has not been thoroughly investigated. The use of wearable devices, which measure some parameters such as the sleep stages, can help to determine the influence of quality sleep in the health state among nursing-home residents. Objective: To analyze the sleep quality and its influence on the daily life of nursing-home residents through the use of assessment tools and Xiaomi MiBand 2. Methods and analysis: This is an observational and analytical study whose objective is the observation and registration of variables of a determined population without the intervention of the researcher and establishing relations between association variables and causality. It is also considered as longitudinal since the follow-up of some of the characteristics of the population will be performed during a period of time. The study is set in a nursing-home in A Coruña (Spain). Xiaomi MiBand 2 will be used to measure biomedical parameters and different assessment tools will be administered to participants for evaluating their sleep quality, cognitive state, and daily functioning. For the statistical analysis, T-Test and ANOVA analysis will be used to compare the means between variables. Also, a Chi-Square test will be used to study the association of qualitative variables. Finally, a multivariate analysis of logistic regression will be performed to determine the variables associated with the presence of the dichotomous variable of interest.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 19, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2018
Actual (reported)December 19, 2019
Actual (reported)December 19, 2019
Actual (reported)October 5, 2020
Actual (reported)October 19, 2020
Actual (reported)Light sleep
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Deep sleep
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Awake time
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Older adults in a nursing-home who report a self-perception of poor sleep quality
Recording of sleep and activity data to study their association with age.
Self-made questionnaire to be administered at the beginning of the study with the following personal data: age, gender, marital status, residential environment, mobility aids, educational level, occupation, retirement type, socioeconomic status, medical records, treatment.
Older adults in a nursing-home who reported a poor sleep quality self-perception.
Universidade da Coruña
A Coruña, 15006, Spain
Bonanni E, Tognoni G, Maestri M, Salvati N, Fabbrini M, Borghetti D, Di Coscio E, Choub A, Sposito R, Pagni C, Iudice A, Murri L. Sleep disturbances in elderly subjects: an epidemiological survey in an Italian district. Acta Neurol Scand. 2010 Dec;122(6):389-97. doi: 10.1111/j.1600-0404.2010.01324.x.
Matthews KA, Patel SR, Pantesco EJ, Buysse DJ, Kamarck TW, Lee L, Hall MH. Similarities and differences in estimates of sleep duration by polysomnography, actigraphy, diary, and self-reported habitual sleep in a community sample. Sleep Health. 2018 Feb;4(1):96-103. doi: 10.1016/j.sleh.2017.10.011. Epub 2017 Dec 13.
Javier Pereira, PhD
Universidade da Coruña
21 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2020
First Posted
October 19, 2020
Study Start
December 19, 2018
Actual (reported)Number of steps
Until the completion of the study (around 1 year)
Distance (meters)
Until the completion of the study (around 1 year)
Duration (minutes)
Until the completion of the study (around 1 year)
Calories
Until the completion of the study (around 1 year)
Quality of life self-perception
Baseline and completion of the study (two months).
Quality of life questionnaire to be administered at the beginning and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100.
Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
Questionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life.
Questionnaire to be administered whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning and completion of the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
El-Amrawy F, Nounou MI. Are Currently Available Wearable Devices for Activity Tracking and Heart Rate Monitoring Accurate, Precise, and Medically Beneficial? Healthc Inform Res. 2015 Oct;21(4):315-20. doi: 10.4258/hir.2015.21.4.315. Epub 2015 Oct 31.
Brown DT, Westbury JL, Schuz B. Sleep and agitation in nursing home residents with and without dementia. Int Psychogeriatr. 2015 Dec;27(12):1945-55. doi: 10.1017/S1041610215001568. Epub 2015 Oct 2.
Shelgikar AV, Anderson PF, Stephens MR. Sleep Tracking, Wearable Technology, and Opportunities for Research and Clinical Care. Chest. 2016 Sep;150(3):732-43. doi: 10.1016/j.chest.2016.04.016. Epub 2016 Apr 29.
Chen JH, Waite L, Kurina LM, Thisted RA, McClintock M, Lauderdale DS. Insomnia symptoms and actigraph-estimated sleep characteristics in a nationally representative sample of older adults. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):185-92. doi: 10.1093/gerona/glu144. Epub 2014 Sep 8.
Puri A, Kim B, Nguyen O, Stolee P, Tung J, Lee J. User Acceptance of Wrist-Worn Activity Trackers Among Community-Dwelling Older Adults: Mixed Method Study. JMIR Mhealth Uhealth. 2017 Nov 15;5(11):e173. doi: 10.2196/mhealth.8211.
Kim M, Yoshida H, Sasai H, Kojima N, Kim H. Association between objectively measured sleep quality and physical function among community-dwelling oldest old Japanese: A cross-sectional study. Geriatr Gerontol Int. 2015 Aug;15(8):1040-8. doi: 10.1111/ggi.12396. Epub 2014 Oct 14.
Rohne M, Boysen ES, Ausen D. Wearable and Mobile Technology for Safe and Active Living. Stud Health Technol Inform. 2017;237:133-139.
Xie J, Wen D, Liang L, Jia Y, Gao L, Lei J. Evaluating the Validity of Current Mainstream Wearable Devices in Fitness Tracking Under Various Physical Activities: Comparative Study. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e94. doi: 10.2196/mhealth.9754.
Valenza MC, Cabrera-Martos I, Martin-Martin L, Perez-Garzon VM, Velarde C, Valenza-Demet G. Nursing homes: impact of sleep disturbances on functionality. Arch Gerontol Geriatr. 2013 May-Jun;56(3):432-6. doi: 10.1016/j.archger.2012.11.011. Epub 2012 Dec 27.
Bernaola-Sagardui I. Validation of the Barthel Index in the Spanish population. Enferm Clin (Engl Ed). 2018 May-Jun;28(3):210-211. doi: 10.1016/j.enfcli.2017.12.001. Epub 2018 Feb 4. No abstract available. English, Spanish.
Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
Li H, Jia J, Yang Z. Mini-Mental State Examination in Elderly Chinese: A Population-Based Normative Study. J Alzheimers Dis. 2016 May 7;53(2):487-96. doi: 10.3233/JAD-160119.
Nieto-Riveiro L, Groba B, Miranda MC, Concheiro P, Pazos A, Pousada T, Pereira J. Technologies for participatory medicine and health promotion in the elderly population. Medicine (Baltimore). 2018 May;97(20):e10791. doi: 10.1097/MD.0000000000010791.
Concheiro-Moscoso P, Groba B, Martinez-Martinez FJ, Miranda-Duro MDC, Nieto-Riveiro L, Pousada T, Pereira J. Use of the Xiaomi Mi Band for sleep monitoring and its influence on the daily life of older people living in a nursing home. Digit Health. 2022 Aug 29;8:20552076221121162. doi: 10.1177/20552076221121162. eCollection 2022 Jan-Dec.
Primary Completion
December 19, 2019
Actual (reported)Study Completion
December 19, 2019
Actual (reported)Last Updated
October 19, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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