RecruitingNot ApplicableNCT06682286

Assessment of Breathing Pattern During NIV

Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study


Sponsor

Fisher and Paykel Healthcare

Enrollment

40 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study measures breathing patterns during nighttime non-invasive ventilation (NIV — a mask-based breathing support machine) in people with COPD (chronic lung disease) or obesity hypoventilation syndrome (OHS), to better understand how well the machine is working. **You may be eligible if...** - You are over 18 years old - You have been prescribed overnight NIV for COPD or OHS - You are able to complete an overnight sleep study - You are comfortable sleeping on a standard double bed **You may NOT be eligible if...** - You have uncontrolled sleep apnea (more than 15 breathing pauses per hour while off your device) - Your breathing machine is set at high pressure levels (above 25 cmH2O) - You are pregnant - You are allergic to the adhesive on the monitoring sensors - You currently have cold or flu symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNIV mask A

Bridge free face mask

OTHERNIV mask B

Full face mask


Locations(1)

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, New Zealand

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NCT06682286


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