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NOT YET RECRUITING
NCT06972589
NA

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

Sponsor: Fisher and Paykel Healthcare

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05

Completion Date

2026-04

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, New Zealand