NCT04926805

Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. Two types of NIV can be delivered; continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two pressures for inhalation and exhalation. This investigation is designed to physiologically evaluate the performance of a NIV mask, Mask A, compared to a standard NIV mask, Mask B on CPAP therapy. People with sleep disordered breathing who have chronic hypercapnia, and are already receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded. Parameters will be recorded during three baselines at the beginning of each evening and throughout the night when participants are asleep. The three baselines are: 1. participant awake with normal breathing (not on CPAP), 2. participant awake and on CPAP, and 3. participant asleep on CPAP in REM-sleep (rapid eye movement sleep).

Conditions

• Sleep-disordered Breathing
• Hypercapnia

Interventions

Type	Name	Description
DEVICE	CPAP with Mask A	CPAP mask
DEVICE	CPAP with Mask B	CPAP mask

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-10-14
• Completion: 2023-07-05
• First posted: 2021-06-15
• Last updated: 2023-07-12

Locations

1 site across 1 country: New Zealand