OurSleepKit To Support CPAP Adherence

Официальное название

OurSleepKit: A Couple-focused m-Health Intervention to Support Adherence to CPAP Treatment

Обзор

The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.

Вмешательства

• Поведенческое OurSleepKit
  OurSleepKit is developed as an app including a patient version and a partner version, to be downloaded on the patient's or partner's mobile devices at home. The goal of OurSleepKit is to coach mutual engagement and model positive partner involvement in CPAP treatment, thus motivating greater CPAP adherence. Using OurSleepKit, both the patient and partner will complete periodic assessments tracking various aspects of their sleep and CPAP use. The assessment data are then processed by OurSleepKit

Первичные конечные точки

• CPAP adherence [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Self-efficacy [Срок оценки: 6 months]
• Functional Status [Срок оценки: 6 months]
• Health-Related Quality of life [Срок оценки: 6 months]
• Dyadic Coping [Срок оценки: 6 months]
• Daytime Sleepiness [Срок оценки: 6 months]
• Sleep Quality and Sleep-related Impairment [Срок оценки: 6 months]
• Partner Involvement in CPAP Treatment [Срок оценки: 6 months]

Критерии участия

Критерии включения

• patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
• The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
• both partners should have their own mobile devices with access to the internet

Критерии исключения

• have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
• have planned bariatric surgery (as they typically quit CPAP after surgery)
• have a partner using CPAP
• are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
• couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.

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

Поддерживающая терапия

Центры проведения

США · 2 центра

• Northeastern University — Boston
• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06621511 · IRB #: 24-04-26 · R01HL160836

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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