Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Assessing breathing patterns during non-invasive ventilation

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

Run by Fisher and Paykel Healthcare · NCT06682286 · Data updated 2026-11-12

This study is testing which of two different masks used in non-invasive ventilation helps people with COPD and Obesity Hypoventilation Syndrome breathe better and feel more comfortable.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorFisher and Paykel Healthcare
Industry-sponsored
Locations1 site (Auckland)
StatusRecruiting
StartedJanuary 24, 2025
Main results expectedSeptember 2025
Study endsSeptember 2025
Registry record updatedMay 11, 2025
Trial IDNCT06682286 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old who are prescribed nocturnal NIV for COPD or OHS and can complete an overnight sleep study.

Probably not a fit

Patients with uncontrolled sleep apnea or those requiring high levels of airway pressure support may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of different masks used in non-invasive ventilation (NIV) for patients with Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS). Participants will undergo a series of breathing assessments while using two different NIV masks to determine which provides better comfort and breathing support. The study involves both awake and overnight assessments to gather comprehensive data on breathing patterns and mask efficacy. The goal is to improve long-term NIV management and patient outcomes.

Why it matters

Potential benefit: If successful, this study could enhance the comfort and effectiveness of NIV therapy for patients with COPD and OHS, leading to better symptom management and quality of life.

How similar studies have gone: While studies on NIV have been conducted, this specific approach to comparing mask types in long-term users is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Fisher and Paykel Healthcare Sleep Laboratory
    Auckland, New Zealand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.