About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Prescribed nocturnal NIV for COPD or OHS
Able to complete an overnight sleep study
Comfortable to sleep on a standard double bed
Disqualifiers
Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
Prescribed IPAP above 25 cmH2O
Self-reported pregnancy
Allergic to adhesive of the sensors
Trial design
Crossover
Treatments tested in this trial
NIV mask A
Other interventionBridge free face mask
NIV mask B
Other interventionFull face mask
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
Sponsors and contacts
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