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NCT06682286Recruiting

Assessment of Breathing Pattern During NIV

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

Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
5 Nov 2024
Start date
24 Jan 2025
Primary completion date
Sept 2025
Lead sponsor
Fisher and Paykel Healthcare
Diseases
Obesity, COPD
NCT number
NCT06682286

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 24 Jan 2025 to the primary completion date, Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Allergic to adhesive of the sensors

Other

  • Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
  • Prescribed IPAP above 25 cmH2O
  • Self-reported pregnancy
  • Self-reported cold/flu symptoms

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fisher and Paykel Healthcare Sleep Laboratory
Coordinator of this site? Confirm its status
AucklandNew ZealandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.