Clinical trial NCT04592796: Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents
Official title: Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents, Through the Use of Wearable Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Cognitive Impairment
Quality of Life
Age Problem
Aging
Keywords: Sleep
Aging
Participatory Health
Quality of life
Daily functioning
Occupational therapy
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Center on Information and Communication Technologies
First posted: 2020-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults in a nursing-home who reported a poor sleep quality self-perception.

Brief summary: 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.

Detailed description: Introduction: In the aging, some disturbance in the health state, as poor sleep quality or a sleep disorder, are likely to appear. The disturbances in sleep stages can influence cognitive state, quality of life, and daily functioning. The progressive aging of the population has led to an increase in resources for the direct care of older people, with a 60.9% of increase in recent years in Spain. Yet, the sleep role in the health state and the activities of daily life from older adults in nursing-home and daily centers hasn't been thoroughly researched. On this issue, wearable devices, which were developed in the last years, monitor the sleep stages and the activity that people perform.

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.

Eligibility criteria: Inclusion Criteria:

* To be at least 65 years old
* To be a resident of the nursing home where the study will be conducted

Exclusion Criteria:

* To have serious acute complications in health status that prevent participation in the registration of occupations and mood, as well as, in the rest of the activities destined to the registration of data.
* 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

Primary outcomes:
measure: Light sleep
timeFrame: Until the completion of the study (around 1 year)
measure: Deep sleep
timeFrame: Until the completion of the study (around 1 year)
measure: Awake time
timeFrame: Until the completion of the study (around 1 year)
Secondary outcomes:
measure: Number of steps
timeFrame: Until the completion of the study (around 1 year)
measure: Distance (meters)
timeFrame: Until the completion of the study (around 1 year)
measure: Duration (minutes)
timeFrame: Until the completion of the study (around 1 year)
measure: Calories
timeFrame: Until the completion of the study (around 1 year)
measure: Quality of life self-perception
timeFrame: Baseline and completion of the study (two months).
measure: Cognitive state
timeFrame: Baseline and completion of the study (two months).
measure: Independence on Activities of daily life
timeFrame: Baseline and completion of the study (two months).
measure: Sleep quality
timeFrame: Baseline and completion of the study (two months).
measure: Gait and balance
timeFrame: Baseline and completion of the study (two months).
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Universidade da Coruña
Study officials:
affiliation: Universidade da Coruña
name: Javier Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
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