- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07819409
Sleep Detection in Residents of Long-term Care Facilities
Sleep Detection in Older Adults Living in Long-term Care Facilities: An Inter-rater Reliability Agreement Study
Sleep disorders are common among older people. People who suffer from sleep disorders typically have difficulty falling asleep, staying asleep, wake up early and do not get restful sleep.
Research on sleep disorders in humans is already underway. Previous research projects in humans have shown that sleep disorders have an impact on bodily functions and quality of life. Disruptions to the sleep-wake cycle can also affect memory. Previous research projects have examined the measurement differences between polysomnography, an overnight sleep measurement in a sleep laboratory, which is currently the gold standard, and various contactless sleep sensor systems. The measurement differences are minor to moderate. However, the investigators do not yet know how large the difference is between different days when using contactless sleep sensor systems in order to determine the accuracy of such devices for residents in retirement and nursing homes.
In this research project, the investigator are therefore investigating sleep variability over a period of 14 days in 52 residents of retirement and nursing homes in Switzerland in order to be able to assess the smallest detectable difference in sleep quality.
The investigators are conducting this research project in accordance with Swiss law. The investigators also comply with all internationally recognized guidelines. The responsible ethics committee has reviewed and approved the research project.
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Eling D de Bruin, Prof. Dr.
- Номер телефона: +41 58 257 14 11
- Электронная почта: eling.debruin@ost.ch
Учебное резервное копирование контактов
- Имя: Andrea C Hausheer
- Номер телефона: +41 58 257 14 77
- Электронная почта: andrea.hausheer@ost.ch
Места учебы
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St.Gallen
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Sankt Gallen, St.Gallen, Швейцария, 9001
- Рекрутинг
- Easternswiss University of Applied Sciences
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Signed informed consent
- Older adults living in the long-term care facilities
Exclusion Criteria:
- Neurocognitive disorders based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to patient record
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
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residents of long-term care facilities without any neurocognitive disorders
residents of long-term care facilities without any neurocognitive disorders according to patient record
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Total Sleep Time
Временное ограничение: From enrollment to 14 days after
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The time a person lying in bed actually sleeping
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From enrollment to 14 days after
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Соавторы и исследователи
Следователи
- Главный следователь: Eling D de Bruin, Prof. Dr., Eastern Swiss University of Applied Sciences, ETH Zruich
Публикации и полезные ссылки
Общие публикации
- Patel D, Steinberg J, Patel P. Insomnia in the Elderly: A Review. J Clin Sleep Med. 2018 Jun 15;14(6):1017-1024. doi: 10.5664/jcsm.7172.
- Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.
- Lee T, Cho Y, Cha KS, Jung J, Cho J, Kim H, Kim D, Hong J, Lee D, Keum M, Kushida CA, Yoon IY, Kim JW. Accuracy of 11 Wearable, Nearable, and Airable Consumer Sleep Trackers: Prospective Multicenter Validation Study. JMIR Mhealth Uhealth. 2023 Nov 2;11:e50983. doi: 10.2196/50983.
- Oskarsdottir M, Islind AS, August E, Arnardottir ES, Patou F, Maier AM. Importance of Getting Enough Sleep and Daily Activity Data to Assess Variability: Longitudinal Observational Study. JMIR Form Res. 2022 Feb 22;6(2):e31807. doi: 10.2196/31807.
- Perez-Pozuelo I, Zhai B, Palotti J, Mall R, Aupetit M, Garcia-Gomez JM, Taheri S, Guan Y, Fernandez-Luque L. The future of sleep health: a data-driven revolution in sleep science and medicine. NPJ Digit Med. 2020 Mar 23;3:42. doi: 10.1038/s41746-020-0244-4. eCollection 2020.
- de Zambotti M, Menghini L, Grandner MA, Redline S, Zhang Y, Wallace ML, Buxton OM. Rigorous performance evaluation (previously, "validation") for informed use of new technologies for sleep health measurement. Sleep Health. 2022 Jun;8(3):263-269. doi: 10.1016/j.sleh.2022.02.006. Epub 2022 May 3.
- G Ravindran KK, Della Monica C, Atzori G, Lambert D, Hassanin H, Revell V, Dijk DJ. Three Contactless Sleep Technologies Compared With Actigraphy and Polysomnography in a Heterogeneous Group of Older Men and Women in a Model of Mild Sleep Disturbance: Sleep Laboratory Study. JMIR Mhealth Uhealth. 2023 Oct 25;11:e46338. doi: 10.2196/46338.
- Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.
- Leng Y, Redline S, Stone KL, Ancoli-Israel S, Yaffe K. Objective napping, cognitive decline, and risk of cognitive impairment in older men. Alzheimers Dement. 2019 Aug;15(8):1039-1047. doi: 10.1016/j.jalz.2019.04.009. Epub 2019 Jun 18.
- Owusu JT, Wennberg AMV, Holingue CB, Tzuang M, Abeson KD, Spira AP. Napping characteristics and cognitive performance in older adults. Int J Geriatr Psychiatry. 2019 Jan;34(1):87-96. doi: 10.1002/gps.4991. Epub 2018 Oct 12.
- Li P, Gao L, Yu L, Zheng X, Ulsa MC, Yang HW, Gaba A, Yaffe K, Bennett DA, Buchman AS, Hu K, Leng Y. Daytime napping and Alzheimer's dementia: A potential bidirectional relationship. Alzheimers Dement. 2023 Jan;19(1):158-168. doi: 10.1002/alz.12636. Epub 2022 Mar 17.
- Cross N, Terpening Z, Rogers NL, Duffy SL, Hickie IB, Lewis SJ, Naismith SL. Napping in older people 'at risk' of dementia: relationships with depression, cognition, medical burden and sleep quality. J Sleep Res. 2015 Oct;24(5):494-502. doi: 10.1111/jsr.12313. Epub 2015 Jun 21.
- Winsky-Sommerer R, de Oliveira P, Loomis S, Wafford K, Dijk DJ, Gilmour G. Disturbances of sleep quality, timing and structure and their relationship with other neuropsychiatric symptoms in Alzheimer's disease and schizophrenia: Insights from studies in patient populations and animal models. Neurosci Biobehav Rev. 2019 Feb;97:112-137. doi: 10.1016/j.neubiorev.2018.09.027. Epub 2018 Oct 9.
- Balouch S, Dijk DAD, Rusted J, Skene SS, Tabet N, Dijk DJ. Night-to-night variation in sleep associates with day-to-day variation in vigilance, cognition, memory, and behavioral problems in Alzheimer's disease. Alzheimers Dement (Amst). 2022 May 16;14(1):e12303. doi: 10.1002/dad2.12303. eCollection 2022.
- Fung CH, Vitiello MV, Alessi CA, Kuchel GA; AGS/NIA Sleep Conference Planning Committee and Faculty. Report and Research Agenda of the American Geriatrics Society and National Institute on Aging Bedside-to-Bench Conference on Sleep, Circadian Rhythms, and Aging: New Avenues for Improving Brain Health, Physical Health, and Functioning. J Am Geriatr Soc. 2016 Dec;64(12):e238-e247. doi: 10.1111/jgs.14493. Epub 2016 Nov 14.
- Ebben MR. Insomnia: Behavioral Treatment in the Elderly. Clin Geriatr Med. 2021 Aug;37(3):387-399. doi: 10.1016/j.cger.2021.04.002. Epub 2021 Jun 4.
- Flaxer JM, Heyer A, Francois D. Evidenced-Based Review and Evaluation of Clinical Significance: Nonpharmacological and Pharmacological Treatment of Insomnia in the Elderly. Am J Geriatr Psychiatry. 2021 Jun;29(6):585-603. doi: 10.1016/j.jagp.2020.10.011. Epub 2020 Oct 27.
- Samara MT, Huhn M, Chiocchia V, Schneider-Thoma J, Wiegand M, Salanti G, Leucht S. Efficacy, acceptability, and tolerability of all available treatments for insomnia in the elderly: a systematic review and network meta-analysis. Acta Psychiatr Scand. 2020 Jul;142(1):6-17. doi: 10.1111/acps.13201. Epub 2020 Jun 30.
- Orhan FO, Tuncel D, Tas F, Demirci N, Ozer A, Karaaslan MF. Relationship between sleep quality and depression among elderly nursing home residents in Turkey. Sleep Breath. 2012 Dec;16(4):1059-67. doi: 10.1007/s11325-011-0601-2. Epub 2011 Nov 27.
- Dopheide JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Am J Manag Care. 2020 Mar;26(4 Suppl):S76-S84. doi: 10.37765/ajmc.2020.42769.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SleepDetection
- 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-00629 (Идентификатор реестра: Eastern Swiss Ethics Committee)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .