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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • NIV mask A

    Other intervention

    Bridge free face mask

  • NIV mask B

    Other intervention

    Full face mask

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Breathing route assessment: Awake and off pressure supportNo intervention 0 interventions
Group B: Breathing route assessment: Awake and on pressure supportExperimental treatment 2 interventions
Group C: Breathing route assessment: Asleep and on pressure supportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.