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Идёт набор NCT06227572

Cognition After OSA Treatment Among Native American People (CATNAP)

Без фазы С лечением Obstructive Sleep Apnea Cognitive Change

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: CATNAP MI.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea, Cognitive Change. Базовые параметры: от 40 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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Официальное название

Cognition After Obstructive Sleep Apnea (OSA) Treatment Among Native American People (CATNAP)

Обзор

This research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias in American Indians. The project will work with American Indian Elders, aged 50 years and older, from three Northern Plains Reservations and surrounding communities. A total of 300 American Indian elders with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP MI component (intervention condition).

Подробное описание

The investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "Cognition After Obstructive Sleep Apnea (OSA) Among Native American People" (CATNAP) to: 1) provide participants with Motivational Interviewing sessions to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias (ADRD) in American Indians and 2) provide participants with electronic messaging to support PAP adherence among American Indian elders, aged 50 years and older.

This study will explore the relationship between OSA and cognitive function and evaluate OSA as a mechanism for the strong association between sleep disorders and Alzheimer's disease and related dementias (ADRD). CATNAP will be implemented as a randomized controlled trial at 4 community sites serving American Indians in the Northern Plains. A total of 300 American Indian elders, aged 50 years and older, with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP component (intervention condition).

The primary outcome is PAP adherence and secondary outcome cognitive function. The study will partner with Missouri Breaks Industries Research Inc., and Missouri Breaks Durable Medical Equipment to monitor participants PAP use, which is uploaded automatically to the cloud. Outcomes will be measured at baseline, 3-months, and 9-months.

Вмешательства

  • Поведенческое CATNAP MI
    Three motivational interviewing (MI) sessions will be facilitated by trained MI staff and will focus on improving participants' knowledge about their OSA diagnosis, understanding of sleep health, and increasing PAP use. Sessions will also provide information about health benefits associated with good sleep and will help participants create an action plan regarding their PAP use and indicators of success, when appropriate. Electronic messaging will be standardized for frequency and content but p

Первичные конечные точки

  • Positive Airway Pressure (PAP) minutes per night [Срок оценки: 9 months]
  • Nights of PAP use [Срок оценки: 9 months]
  • PAP adherence [Срок оценки: 9-months]
Вторичные конечные точки (2)
  • Montreal Cognitive Assessment total score [Срок оценки: 9 months]
  • Cognivue total score [Срок оценки: 9 months]

Критерии участия

Критерии включения

  • Age 50 years and older
  • Self report American Indian or Alaskan Native
  • diagnosed with obstructive sleep apnea
  • prescribed PAP therapy and have a device
  • \*Ability to understand written and spoken English; and
  • \*Ability and willingness to follow all study protocols.

Критерии исключения

  • Living in a household with someone who is enrolled in the study
  • Already using PAP device at Medicaid recommended standards
  • Cognitive decline, unable to consent on their own

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Missouri Breaks Industries Research Inc — Eagle Butte

Идентификаторы

NCT: NCT06227572 · P01AG066584

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗