Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents
NCT ID: NCT04592796
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
21 participants
OBSERVATIONAL
2018-12-19
2019-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands
NCT04568408
Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
NCT06363656
Accuracy Assessment of Sleep Monitoring Technology
NCT05636930
Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"
NCT05696496
Self-Management of Sleep Among Older Adults
NCT03837249
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective: The main objective of this study will be 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. Secondary objectives are 1) To know the situation of older people in a nursing-home, recording general data, results of assessment instruments and data obtained from Xiaomi MiBand 2; 2) To explore and determine the quality of life and daily functioning of the participating older people; 3) To determine the level of the cognitive state of the participating older people; 4) To analyze the level of physical activity and the quality of sleep, as well as the factors linked to both constructs, in the older adults who are in a residence; 5) to promote the use of technological devices in the daily life of older adults, especially for the empowerment and management of their health.
Methods and Analysis: It is proposed to carry out 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. Likewise, this study is considered as longitudinal since the follow-up of the characteristics of this population will be carried out during a period of time (variables will be followed for 1 year). Specifically, the physical activity and the sleep of the participating population will be continuously registered and monitored throughout the entire study. The study will be developed with the resident population in a nursing-home in A Coruña (Spain). To measure biomedical parameters from users, it will be used the Xiaomi MiBand 2. Besides, different assessment tools will be administered to the participants related to self-perception of sleep quality, cognitive state, and daily functioning.
For the statistical analysis, quantitative variables will be expressed as mean and standard deviation, while qualitative variables will be expressed as absolute value and percentage.
To compare means between them, the Student t-test will be used, and for the multiple comparisons of means, the analysis of variance will be used. This design is applied when the data are paired, that is when they come from subjects with variables measured before and after treatment. This test makes it possible to determine whether the differences between the values of both variables are statistically significant or whether they are differences due to chance. To study the association of the qualitative variables, the Chi-square test will be used.
On the other hand, to determine the variables that are associated or not with the presence of the dichotomous variable of interest, a multivariate analysis of logistic regression will be performed, using as a dependent variable the presence or not of the event of interest, and as covariates, the variables that in the bivariate analysis are associated with the presence of said event or are clinically relevant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nursing-home residents
Older adults in a nursing-home who report a self-perception of poor sleep quality
Xiaomi MiBand2
Recording of sleep and activity data to study their association with age.
Socio-demographic questionnaire
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.
EuroQol-5D-5L
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.
Mini mental State Examination
Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
Tinetti Scale
Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
Barthel Index
Questionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life.
Pittsburgh Sleep Quality Assessment (PSQI)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xiaomi MiBand2
Recording of sleep and activity data to study their association with age.
Socio-demographic questionnaire
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.
EuroQol-5D-5L
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.
Mini mental State Examination
Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
Tinetti Scale
Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
Barthel Index
Questionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life.
Pittsburgh Sleep Quality Assessment (PSQI)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* To be a resident of the nursing home where the study will be conducted
Exclusion Criteria
* To be in the final stages of a terminal illness. This criterion mainly excludes those people who have a diagnosis of an irreversible and progressive disease or condition, with a fatal prognosis in the near future or in a relatively short time, which prevents the person from participating in the whole study.
* To be in a situation of request to be transferred to another center.
* To have a temporary stay
* To be in a situation of legal incapacity
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center on Information and Communication Technologies
OTHER
Universidade da Coruña
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Javier Pereira
Professor PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Javier Pereira, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade da Coruña
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade da Coruña
A Coruña, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Life Expectancy in Spain
Residential statistics: distribution of centers and nursing-home places by provinces
Euroqol group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018/473
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.