Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

NCT04926805 NA TERMINATED

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).

Details

Lead sponsor	Fisher and Paykel Healthcare
Phase	NA
Status	TERMINATED
Enrolment	40
Start date	Wed Jul 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Sleep-disordered Breathing
• Hypercapnia

Interventions

• CPAP with Mask A
• CPAP with Mask B

Countries

New Zealand