PAP Systems External Clinical Studies (ECS)

Официальное название

External Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing

Обзор

This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.

Подробное описание

This is an open label, prospective, randomized cross over (or single arm) study for ongoing product development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies phases, each of which will have their own sub-protocol outlining the exact specifics of the study.

The studies could be run face-to-face or remotely.

Participants who met the inclusion/exclusion criteria will be contacted. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.

Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.

Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Вмешательства

• Устройство PAP System A (with Amalfi) then PAP System B (with CLA11)
  PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
• Устройство PAP System B (with CLA11) then PAP System A (with Amalfi)
  PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days

Первичные конечные точки

• (usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6 [Срок оценки: 6 weeks]
• (efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Participants willing to give written informed consent
• Participants who ≥ 18 years of age
• Participants being treated for OSA for ≥ 3 months
• Participants currently using a suitable PAP system(s)
• Participants who can trial the PAP systems for up to 7 nights each

Additional criteria for remote studies:

• Participants currently using PAP device compatible with AirView, or with download capacity from PAP machine from data cards
• Participants who have access to video call equipment

Критерии исключения

• Participants using Bilevel flow generators
• Participants who are or may be pregnant
• Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Participants believed to be unsuitable for inclusion by the researcher
• Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
• Participants who are currently enrolled in other clinical studies

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06562205 · SLP-24-08-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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