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

NCT04592796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Center on Information and Communication Technologies

    collaborator OTHER
  • Universidade da Coruña

    lead OTHER

Principal Investigators

  • Javier Pereira, PhD · Universidade da Coruña

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592796 on ClinicalTrials.gov