Clinical trial

Assessment of Breathing Pattern During NIV

Recruiting now · Not applicable · 1 countries · Registry ID NCT06682286

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionCOPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)

Full registry criteria

Inclusion Criteria: * 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 * Capacity to complete informed consent Exclusion Criteria: * 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 * Self-reported cold/flu symptoms

Treatments and study arms

NIV mask A

Other

Bridge free face mask

NIV mask B

Other

Full face mask

Primary outcomes

Breathing route while on and off pressure support (awake)4 hours

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)8 hours

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)12 hours

Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fisher and Paykel Healthcare Sleep Laboratory🇳🇿 Auckland, New Zealand

Open map

Jessica FogarinContact

Email · Call 7327

Valeria MereacreSub Investigator

William R Good, Medical degreePrincipal Investigator