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Набор скоро начнётся NCT06045988

Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease

Без фазы С лечением Alzheimer Disease Dementia Sleep Disturbance

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: Non-Contact Sleep Quality Monitor System.
Кому может быть актуально
Состояния в реестре: Alzheimer Disease, Dementia, Sleep Disturbance. Базовые параметры: от 18 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
США
Следующий шаг
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Обзор

This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD/ADRD participants in the intervention group as compared to the control group. All subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

Подробное описание

The purpose of this study is to evaluate the utility of a Non-Contact Sleep Quality Monitor System and determine the effect that sharing System Sleep Data with long-term care (LTC) staff and healthcare providers has on documentation and treatment of sleep disorders and change in AD/ADRD participant sleep quality. System Sleep Data will be collected for a total of 4-weeks. During the Intervention condition System Sleep Data will be shared for 2-weeks, while in the initial Control condition no System Sleep Data will be shared for 2-weeks. Healthcare providers can prescribe a non-pharmacologic sleep protocol and/or if they so choose, pharmacotherapy to manage sleep disturbances for subjects in either the Intervention or Control condition, in accordance with standard medical practice. The investigators hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

Вмешательства

  • Устройство Non-Contact Sleep Quality Monitor System
    Residents of long-term care facilities with Alzheimer's or other related dementias will utilize a sleep monitoring device for the four-week period they are involved in the study.

Первичные конечные точки

  • Documentation of sleep disorders or treatment [Срок оценки: 4-weeks]
Вторичные конечные точки (9)
  • Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST) [Срок оценки: 4-weeks]
  • Change in Epworth Sleepiness Scale Total Score Over Time [Срок оценки: 4-weeks]
  • Change in QOL-AD Over Time [Срок оценки: 4-weeks]
  • Attitudes Toward Technology [Срок оценки: 4-weeks]
  • Technology Acceptance Survey Questionnaire [Срок оценки: 4-weeks]
  • System Usage [Срок оценки: 4-weeks]
  • Change in Sleep Quality Over Time: Sleep Efficiency (SE) [Срок оценки: 4-weeks]
  • Change in Sleep Quality Over Time: Sleep Onset Latency (SOL) [Срок оценки: 4-weeks]
  • Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO) [Срок оценки: 4-weeks]

Критерии участия

Критерии включения

  • Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)
  • Residents of long-term care (LTC) facility study site location for a minimum of 30 days.
  • Willingness to consent to study or when a potential participant lacks decision making capacity (determined by LTC facility clinical provider) willingness of a Legally Authorized Representative (LAR) to consent to study participation on potential participant's behalf.

Критерии исключения

  • Currently on hospice

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Indiana University School of Medicine — Indianapolis

Идентификаторы

NCT: NCT06045988 · 15771 · 2R44AG058339-02A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗