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Идёт набор NCT06490783

Cyber-Human Systems for Personalized Well-being and Health

— Наблюдательное Geriatric Health Services Health Services for the Elderly

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Noninvasive wearable devices (smartwatch and heart rate monitor band).
Кому может быть актуально
Состояния в реестре: Geriatric Health Services, Health Services for the Elderly. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health

Обзор

The purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. The study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action/interaction, possibly supported and stimulated by individualized and easily usable activities. The signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. The collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.

Вмешательства

  • Другое Noninvasive wearable devices (smartwatch and heart rate monitor band)
    Each enrolled subject will be equipped with noninvasive wearable devices (smartwatch and heart rate monitor band) to monitor physiological parameters and emotional states related to anxiety and stress. Each subject will be required to wear the smartwatch on his or her wrist for the duration of the study, about 3-6 months; while the heart rate monitor band will be worn for about 10 minutes a day. At the same time, a mobile application, RESILIENT, will be developed and implemented to serve as the

Первичные конечные точки

  • Heart Rate(HR) [Срок оценки: Through study completion, an average of 1 year]
  • Heart rate variability (HRV) [Срок оценки: Through study completion, an average of 1 year]
  • Facial emotion recognition [Срок оценки: Through study completion, an average of 1 year]
  • Steps taken [Срок оценки: Through study completion, an average of 1 year]
  • Distance traveled [Срок оценки: Through study completion, an average of 1 year]
  • Calories burned [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • healthy male and female aged 60 years and older
  • signing of informed consent

Критерии исключения

  • chronic diseases
  • cardiovascular disease
  • presence of dementia and/or depression
  • presence of confirmed paranoid or psychotic symptoms

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), — Messina

Публикации

  • Abd-Alrazaq A, Alhuwail D, Schneider J, Toro CT, Ahmed A, Alzubaidi M, Alajlani M, Househ M. The performance of artificial intelligence-driven technologies in diagnosing mental disorders: an umbrella review. NPJ Digit Med. 2022 Jul 7;5(1):87. doi: 10.1038/s41746-022-00631-8. PMID 35798934
  • Jan et al.
  • Panicker et al.

Идентификаторы

NCT: NCT06490783 · CNR-IRIB-PRO-2024-009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗