COPD (Chronic Obstructive Pulmonary Disease)NCT06972589
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
A study testing Investigational Mask and Conventional mask in people with COPD (Chronic Obstructive Pulmonary Disease) and Obesity Hypoventilation Syndrome (OHS), run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Investigational Mask and Conventional mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
- Prescribed IPAP above 25 cmH2O
- Allergic to adhesive of the sensors
- Self-reported cold/flu symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Fogarin contact
New Zealand1 site
Fisher and Paykel Healthcare Sleep Laboratory
Auckland, 2013
Jessica Fogarin, 7327, jess.fogarin@fphcare.co.nz
val.mereacre@fphcare.co.nz
About this study
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and 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. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.
Read the detailed description
Participants are moved to the sleep laboratory for the night where they are provided with beds.
- The participants are put on their prescribed airway pressure support with the first randomized mask.
- After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.
- Being tested
- Investigational Mask, Conventional mask
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational MaskDevice
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
Conventional maskDevice
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the investigational mask | Experimental | Not described Receives: Device: Investigational Mask |
| Noninvasive ventilation (CPAP or bilevel) with the conventional mask | Active comparator | Not described Receives: Device: Conventional mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory rate
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study startMay 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Good, Medical degree, Principal investigator, Middlemore Hospital, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972589
- Sponsor's protocol ID
- U1111-1322-0270
- Other IDs
- CIA-356
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
- ClinicalTrials.gov ID
- NCT06972589
- Acronym / sponsor ID
- U1111-1322-0270
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and 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. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.
Detailed description
Participants are moved to the sleep laboratory for the night where they are provided with beds.
- The participants are put on their prescribed airway pressure support with the first randomized mask.
- After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the investigational mask | Experimental | Device: Investigational Mask |
| Noninvasive ventilation (CPAP or bilevel) with the conventional mask | Active comparator | Device: Conventional mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
- Prescribed IPAP above 25 cmH2O
- Allergic to adhesive of the sensors
- Self-reported cold/flu symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational MaskWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep. | Device | Noninvasive ventilation (CPAP or bilevel) with the investigational mask |
| Conventional maskWear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep. | Device | Noninvasive ventilation (CPAP or bilevel) with the conventional mask |
Primary outcome
Change in respiratory rate
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Fogarin contact
William Good, Medical degree principal investigator
Middlemore Hospital, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Mask and Conventional mask in people with COPD (Chronic Obstructive Pulmonary Disease) and Obesity Hypoventilation Syndrome (OHS), run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Mereacre, PhD Physiology (02102819036, val.mereacre@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in respiratory rate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.