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

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.

NCT Number	NCT06972589
Lead Sponsor	Fisher and Paykel Healthcare
Conditions	COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Enrollment	20 participants
Start Date	2025-05
Primary Completion	2026-04 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2025-05-15