SleepNCT04592796
Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents
An observational study of Sleep and Cognitive Impairment, run by Universidade da Coruña at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sleep, Cognitive Impairment, Quality of Life
- What is being tested?
- Xiaomi MiBand2, Socio-demographic questionnaire and EuroQol-5D-5L
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 19 Dec 2018to 19 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults in a nursing-home who reported a poor sleep quality self-perception.
Who may be able to join
- To be at least 65 years old
- To be a resident of the nursing home where the study will be conducted
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Sleep, Cognitive Impairment, Quality of Life, Age Problem, Aging
- Being tested
- Xiaomi MiBand2, Socio-demographic questionnaire, EuroQol-5D-5L, Mini mental State Examination, Tinetti Scale
- Keywords
- Sleep, Aging, Participatory Health, Quality of life, Daily functioning, Occupational therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaomi MiBand2Device
Recording of sleep and activity data to study their association with age.
Socio-demographic questionnaireOther
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-5LOther
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 ExaminationOther
Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
Tinetti ScaleOther
Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
Barthel IndexOther
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Nursing-home residents | Older adults in a nursing-home who report a self-perception of poor sleep quality Receives: Device: Xiaomi MiBand2; Other: Socio-demographic questionnaire; Other: EuroQol-5D-5L; Other: Mini mental State Examination; Other: Tinetti Scale; Other: Barthel Index; Other: Pittsburgh Sleep Quality Assessment (PSQI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light sleep
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Deep sleep
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Awake time
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Secondary outcomes (9)
Number of steps
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Distance (meters)
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Duration (minutes)
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Calories
Measured by Xiaomi MiBand 2
Measured: Until the completion of the study (around 1 year)
Quality of life self-perception
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).
Measured: Baseline and completion of the study (two months).
Cognitive state
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).
Measured: Baseline and completion of the study (two months).
Independence on Activities of daily life
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.
Measured: Baseline and completion of the study (two months).
Sleep quality
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.
Measured: Baseline and completion of the study (two months).
Gait and balance
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.
Measured: Baseline and completion of the study (two months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Dec 2018
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Center on Information and Communication Technologies
- Responsible party
- Principal investigator, Javier Pereira, Universidade da Coruña
- Investigators
- Javier Pereira, PhD, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592796
- Sponsor's protocol ID
- 2018/473
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20175759Matthews 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.
PubMed 29332687El-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.
PubMed 26618039Brown 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.
PubMed 26424155Shelgikar 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.
PubMed 27132701Chen 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.
PubMed 25199910Puri 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.
PubMed 29141837Kim 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.
PubMed 25312049Rohne M, Boysen ES, Ausen D. Wearable and Mobile Technology for Safe and Active Living. Stud Health Technol Inform. 2017;237:133-139.
PubMed 28479556Xie 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.
PubMed 29650506Valenza 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.
PubMed 23273670Bernaola-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.
PubMed 29397315Tinetti 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.
PubMed 3944402Mollayeva 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.
PubMed 26163057Li 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.
PubMed 27163822
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study About Sleep Quality and Its Impact on Daily Life of Nursing-home Residents, Through the Use of Wearable Technologies
- ClinicalTrials.gov ID
- NCT04592796
- Acronym / sponsor ID
- 2018/473
- Conditions
- Sleep, Cognitive Impairment, Quality of Life, Age Problem, Aging
- Keywords
- Sleep, Aging, Participatory Health, Quality of life, Daily functioning, Occupational therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Center on Information and Communication Technologies
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing-home residents | – | Device: Xiaomi MiBand2, Other: Socio-demographic questionnaire, Other: EuroQol-5D-5L, Other: Mini mental State Examination, Other: Tinetti Scale, Other: Barthel Index, Other: Pittsburgh Sleep Quality Assessment (PSQI)Older adults in a nursing-home who report a self-perception of poor sleep quality |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults in a nursing-home who reported a poor sleep quality self-perception.
Key inclusion criteria (2 listed)
- To be at least 65 years old
- To be a resident of the nursing home where the study will be conducted
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaomi MiBand2Recording of sleep and activity data to study their association with age. | Device | Nursing-home residents |
| Socio-demographic questionnaireSelf-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 | Nursing-home residents |
| EuroQol-5D-5LQuality 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 | Nursing-home residents |
| Mini mental State ExaminationQuestionnaire to be administered at the beginning and completion of the study that measures cognitive impairment. | Other | Nursing-home residents |
| Tinetti ScalePhysical test to be administered at the beginning and completion of the study that measures gait and balance of the participants. | Other | Nursing-home residents |
| Barthel IndexQuestionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life. | Other | Nursing-home residents |
| 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. | Other | Nursing-home residents |
Primary outcome
Light sleep
Time frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Deep sleep
Time frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
Awake time
Time frame: Until the completion of the study (around 1 year)
Measured by Xiaomi MiBand 2
9 secondary outcomes
Number of steps
Time frame: Until the completion of the study (around 1 year)
Distance (meters)
Time frame: Until the completion of the study (around 1 year)
Duration (minutes)
Time frame: Until the completion of the study (around 1 year)
Calories
Time frame: Until the completion of the study (around 1 year)
Quality of life self-perception
Time frame: Baseline and completion of the study (two months).
Cognitive state
Time frame: Baseline and completion of the study (two months).
Independence on Activities of daily life
Time frame: Baseline and completion of the study (two months).
Sleep quality
Time frame: Baseline and completion of the study (two months).
Gait and balance
Time frame: Baseline and completion of the study (two months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 20175759Bonanni 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.
- Background: PubMed 29332687Matthews 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.
- Background: PubMed 26618039El-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.
- Background: PubMed 26424155Brown 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.
- Background: PubMed 27132701Shelgikar 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.
- Background: PubMed 25199910Chen 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.
- Background: PubMed 29141837Puri 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.
- Background: PubMed 25312049Kim 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.
- Background: PubMed 28479556Rohne M, Boysen ES, Ausen D. Wearable and Mobile Technology for Safe and Active Living. Stud Health Technol Inform. 2017;237:133-139.
- Background: PubMed 29650506Xie 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.
- Background: PubMed 23273670Valenza 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.
- Background: PubMed 29397315Bernaola-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.
- Life Expectancy in SpainLink provided by the sponsor.
- Residential statistics: distribution of centers and nursing-home places by provincesLink provided by the sponsor.
- Euroqol groupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Pereira, PhD principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Cognitive Impairment, run by Universidade da Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light sleep (time frame: Until the completion of the study (around 1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592796, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.