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

Official Summary

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

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 130 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: CROSSOVER
• Masking: SINGLE
• Enrollment: 30 participants

Study Arms

• PAP System A (with Amalfi) then PAP System B (with CLA11) (EXPERIMENTAL)
  Participants will be asked to take home the investigational PAP system (Amalfi) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System A and PAP System B. This arm will first use the Amalfi for 7 days and then use the CLA 11 for 7 days.
• PAP System B (with CLA11) then PAP System A (with Amalfi) (ACTIVE_COMPARATOR)
  Participants will be asked to take home the comparator PAP system B (CLA 11) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System B and PAP System A. This arm will first use the CLA 11 for 7 days and then use the Amalfi for 7 days.

Interventions

• DEVICE: 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
• DEVICE: 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

Primary Outcomes

• (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 (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 (6 weeks)

Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Contact Information

• Xueling Zhu Manager - Clinical Data and Operations — CONTACT
  Phone: +61288842367
  Email: xueling.zhu@resmed.com.au

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