Assessment of Breathing Pattern During NIV

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare

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

Qualifiers

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

Treatments tested in this trial

  • NIV mask A
  • NIV mask B

Treatment groups

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators