An interventional study of NIV mask A and NIV mask B in COPD (Chronic Obstructive Pulmonary Disease) and Obesity Hypoventilation Syndrome (OHS), sponsored by Fisher and Paykel Healthcare. Recruiting at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Basic science
COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), 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. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth.
However, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.
Participants are then moved to the sleep laboratory for the night where they are provided with beds.
Exclusion Criteria:
Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min.
Awake participants will be placed on their prescribed pressure support settings and will use two different non-invasive ventilation (NIV) masks, each for about 30 minutes.
Other: NIV mask A · Other: NIV mask B
Participants will be placed on their prescribed pressure support settings and will go to sleep. After 60 minutes, they will be awakened to change their mask. They will use two different non-invasive ventilation (NIV) masks, each for a minimum of 60 minutes
Other: NIV mask A · Other: NIV mask B
Bridge free face mask
Full face mask
Breathing route while on and off pressure support (awake)
Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.
Time frame: 4 hours
Breathing route while on pressure support (asleep)
Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.
Time frame: 8 hours
Mask type influence on breathing route (asleep and awake)
Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type
Time frame: 12 hours
Plan to share: No
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Fisher and Paykel Healthcare