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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 15, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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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.
Trial Details
NCT Number NCT06972589
Lead Sponsor Fisher and Paykel Healthcare
Conditions
(from sponsor)
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Related terms Obesity Hypoventilation Syndrome, Pulmonary Disease, Chronic Obstructive
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov