Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents

October 16, 2020 updated by: Javier Pereira, Universidade da Coruña

Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents, Through the Use of Wearable Technologies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Universidade da Coruña

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older adults in a nursing-home who reported a poor sleep quality self-perception.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nursing-home residents
Older adults in a nursing-home who report a self-perception of poor sleep quality
Device: Xiaomi MiBand2
Recording of sleep and activity data to study their association with age.
Other: 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.
Other: 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.
Other: Mini mental State Examination
Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
Other: Tinetti Scale
Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
Other: Barthel Index
Questionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light sleep
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Deep sleep
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Awake time
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Distance (meters)
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Duration (minutes)
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Calories
Time Frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Until the completion of the study (around 1 year)
Quality of life self-perception
Time Frame: Baseline and completion of the study (two months).
EuroQol 5D-5L measures the quality of life and health status. This questionnaire is made up by three elements: A descriptive system divided into 5 dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression);the levels of Severity considered by the person assessed: 1-Absence of problems, 2-Presence of mild problems, 3-Presence of moderate problems, 4-Presence of severe problems or 5- Presence of severe problems; and the Visual Analogue Scale (VAS) extends from 0 (the worst imaginable state of health), to 100, (the best imaginable state of health).
Baseline and completion of the study (two months).
Cognitive state
Time Frame: Baseline and completion of the study (two months).
Measured by the Mini Mental State Examination (MMSE) test. This tool is used to detect the presence of cognitive impairment. It presents 6 values for each section (Orientation, Fixation, Concentration and calculation, Memory and Language and construction) and their final score. The test has a maximum score of 35 points, with different levels of cognitive impairment from the following scores: Geriatric patients: cut-off point 23/24 (a score lower than 23 implies the existence of cognitive impairment, whereas a score higher than 24 means the absence of cognitive impairment). Non-geriatric patients: cut-off point 27/28 (a score lower than 27 implies the existence of cognitive impairment, whereas a score higher than 28 means the absence of cognitive impairment).
Baseline and completion of the study (two months).
Independence on Activities of daily life
Time Frame: Baseline and completion of the study (two months).
Measured by Barthel Activities of Daily Living (ADL) Index. This tool allows the measurement of the variable "performance in daily life activities". It presents 11 values: one for each item and one for the final score. The person's performance is evaluated based on these scores: < 20: total dependence, 20-40: severe dependence, 45-55: moderate dependence, and 60 or more: slight dependence.
Baseline and completion of the study (two months).
Sleep quality
Time Frame: Baseline and completion of the study (two months).
Measured by the Pittsburgh Sleep Quality Index (PSQI). This questionnaire consists of 24 items, of which 19 are answered by the person him/herself and the other 5 by his/her roommate. This tool analyzes the quantity, quality, duration, latency and efficiency of sleep. The total score of the PSQI scale is the result of adding 7 components. Each component is scored from 0 to 3. The total value of this tool can vary from 0 to 21 points, where a score equal to or less than 5 points corresponds to the absence of difficulties in sleep.
Baseline and completion of the study (two months).
Gait and balance
Time Frame: Baseline and completion of the study (two months).
Measured by the Tinetti scale. This tool is used to determine the falling risk of an older person. The tool is divided into two parts, the assessment of balance on the one hand and the assessment of gait on the other. The range of scores goes from 0 (most impairment) to 2 (represents independence) for each item. The maximum score for the balance test is 16 points, and 12 points for the gait test, so the total score is 28. The higher the final score, the better the patient's functionality and the lower the risk of a fall.
Baseline and completion of the study (two months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Collaborators

Center on Information and Communication Technologies

Investigators

  • Principal Investigator: Javier Pereira, PhD, Universidade da Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2018

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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