NCT05262439

Post Market Clinical Follow Up of ResMed Mask Systems

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

Detailed description

This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	New generation CPAP mask	All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask.

Timeline

• Start date: 2022-05-26
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-03-02
• Last updated: 2024-10-16

Locations

1 site across 1 country: Australia