NCT06173050

PAP Systems Internal Clinical Studies (ICS)

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is an open label, prospective, randomized cross over (or single arm) study designed to support the 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, 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 are healthy volunteers who are ResMed employees. 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-09-01
• Completion: 2029-12-01
• First posted: 2023-12-15
• Last updated: 2024-08-19