Assessing breathing patterns during non-invasive ventilation
Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study
NA · Fisher and Paykel Healthcare · NCT06682286
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fisher and Paykel Healthcare (industry) |
| Locations | 1 site (Auckland) |
| Trial ID | NCT06682286 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled sleep apnea or those requiring high levels of airway pressure support may not benefit from this study.
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 performed: While studies on NIV have been conducted, this specific approach to comparing mask types in long-term users is relatively novel.
Eligibility criteria
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 this trial is running
Auckland
- Fisher and Paykel Healthcare Sleep Laboratory — Auckland, New Zealand (RECRUITING)
Study contacts
- Principal investigator: William Good, Medical degree — Middlemore Hospital, New Zealand
- Study coordinator: Valeria Mereacre, PhD Physiology
- Email: val.mereacre@fphcare.co.nz
- Phone: 0064 2102819036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD, Obesity Hypoventilation Syndrome