Меню
Набор скоро начнётся NCT07447284

The Improving Sleep in African American Couples Study (ISAAC)

Без фазы С лечением Obstructive Sleep Apnea (OSA)

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: CPAP Training and Education, Virtual Disease Support Group Sessions, Couple CPAP Training and Education, Couples Virtual OSA Support Group Sessions.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA). Базовые параметры: от 30 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Improving Sleep in African American Couples (ISAAC) Study

Обзор

The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.

Подробное описание

This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.

Вмешательства

  • Поведенческое CPAP Training and Education
    Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
  • Поведенческое Virtual Disease Support Group Sessions
    Patients will attend 3 virtual webinars on prevention and management of diseases affecting the Black community including hypertension, obesity, cardiovascular disease, and cancer led by African American providers.
  • Поведенческое Couple CPAP Training and Education
    Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
  • Поведенческое Couples Virtual OSA Support Group Sessions
    Patient and their bed partner will participate in 3 virtual group sessions moderated by an African American patient with longstanding OSA who regularly uses CPAP and their bed partner.
  • Поведенческое CPAP Tele-monitoring and Feedback
    Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
  • Поведенческое Couples' Cognitive Behavioral Therapy
    Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.

Первичные конечные точки

  • Mean Nightly CPAP Use at 1 Year [Срок оценки: From enrollment until 1 year.]
Вторичные конечные точки (11)
  • Mean Nightly CPAP Use [Срок оценки: From enrollment to 30 days, 90 days, and 6 months.]
  • Patient and Bed Partner Quality of Sleep [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Patient and Bed Partner Quality of Sleep [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Patient and Bed Partner Quality of Sleep [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Patient and Bed Partner Quality of Sleep [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Patient and Bed Partner Quality of Sleep [Срок оценки: 6 months]
  • Patient and Bed Partner Quality of Life [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Patient and Bed Partner Sleep Apnea Quality of Life [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Sleep Apnea Beliefs [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Sleep Apnea Knowledge [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
  • Self-efficacy to Use CPAP [Срок оценки: From enrollment to 30 days, 90 days, 6 months, and 1 year.]

Критерии участия

Inclusion Criteria - Patient:

  • Moderate or severe OSA (Apnea hypopnea index ≥ 15 events/hour)
  • Age ≥ 30 years
  • Bed partner for ≥ last 6 months who is willing to participate
  • English proficient

Inclusion Criteria - Bed Partner

  • Bed partner for ≥ 6 months and willing to participate
  • English proficient

Exclusion Criteria - Patient:

  • Terminal illness
  • Neurocognitive disorder that prevents informed consent
  • Unstable housing
  • Need for other forms of positive airway pressure (BPAP or VPAP)
  • Pregnancy

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • The MetroHealth System — Cleveland
  • University of Pittsburgh Medical Center — Pittsburgh

Идентификаторы

NCT: NCT07447284 · STUDY00000597 · R01HL169588

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗