NCT06972589

The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.

Detailed description

Participants are moved to the sleep laboratory for the night where they are provided with beds. * The participants are put on their prescribed airway pressure support with the first randomized mask. * After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• Obesity Hypoventilation Syndrome (OHS)

Interventions

Type	Name	Description
DEVICE	Investigational Mask	Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
DEVICE	Conventional mask	Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: New Zealand