COPD (Chronic Obstructive Pulmonary Disease)NCT06682286
Assessment of Breathing Pattern During NIV
A study testing NIV mask A and NIV mask B 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
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. 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?
- NIV mask A and NIV mask B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNew Zealand
- Study dates
- 24 Jan 2025to Sep 2025
- 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
- Self-reported pregnancy
- 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, 1 recruiting
- Recruiting
Fisher and Paykel Healthcare Sleep Laboratory
Auckland, 2013
Jessica Fogarin, 7327, jess.fogarin@fphcare.co.nz
Valeria Mereacre
About this study
Official title: Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study
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.
Read the detailed description
- Participants undergo PSG, lying on their backs while their breathing route is recorded for about 30 minutes.
- The participants are then put on their prescribed airway pressure support with the first randomized mask, and their breathing is recorded again for 30 minutes.
- The mask is switched to the second mask, and the same procedure is repeated.
Participants are then moved to the sleep laboratory for the night where they are provided with beds.
- They continue NIV therapy with the last mask used during the awake test.
- After at least 60 minutes of recording, participants are awakened to switch back to the first mask. They are then allowed to sleep uninterrupted for the rest of the night.
- Being tested
- NIV mask A, NIV mask B
- 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.
NIV mask AOther
Bridge free face mask
NIV mask BOther
Full face mask
| Study group | Role | What they receive |
|---|---|---|
| Breathing route assessment: Awake and off pressure support | No intervention | Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min. |
| Breathing route assessment: Awake and on pressure support | Experimental | Awake participants will be placed on their prescribed pressure support settings and will use two different non-invasive ventilation (NIV) masks, each for about 30 minutes. Receives: Other: NIV mask A; Other: NIV mask B |
| Breathing route assessment: Asleep and on pressure support | Experimental | Participants will be placed on their prescribed pressure support settings and will go to sleep. After 60 minutes, they will be awakened to change their mask. They will use two different non-invasive ventilation (NIV) masks, each for a minimum of 60 minutes Receives: Other: NIV mask A; Other: NIV mask B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
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.
Measured: 8 hours
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start24 Jan 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study where the breathing route of each participant will be assessed off- and on NIV. Additionally, the breathing route of each participant on NIV will be investigated during sleep and in awake state.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06682286
- Sponsor's protocol ID
- U1111-1308-1838
- Status last verified
- May 2025
- First submitted
- 5 Nov 2024
- Last updated
- 11 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study
- ClinicalTrials.gov ID
- NCT06682286
- Acronym / sponsor ID
- U1111-1308-1838
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
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.
Detailed description
- Participants undergo PSG, lying on their backs while their breathing route is recorded for about 30 minutes.
- The participants are then put on their prescribed airway pressure support with the first randomized mask, and their breathing is recorded again for 30 minutes.
- The mask is switched to the second mask, and the same procedure is repeated.
Participants are then moved to the sleep laboratory for the night where they are provided with beds.
- They continue NIV therapy with the last mask used during the awake test.
- After at least 60 minutes of recording, participants are awakened to switch back to the first mask. They are then allowed to sleep uninterrupted for the rest of the night.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover study where the breathing route of each participant will be assessed off- and on NIV. Additionally, the breathing route of each participant on NIV will be investigated during sleep and in awake state.
| Arm | Type | Receives |
|---|---|---|
| Breathing route assessment: Awake and off pressure support | No intervention | –Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min. |
| Breathing route assessment: Awake and on pressure support | Experimental | Other: NIV mask A, Other: NIV mask BAwake participants will be placed on their prescribed pressure support settings and will use two different non-invasive ventilation (NIV) masks, each for about 30 minutes. |
| Breathing route assessment: Asleep and on pressure support | Experimental | Other: NIV mask A, Other: NIV mask BParticipants will be placed on their prescribed pressure support settings and will go to sleep. After 60 minutes, they will be awakened to change their mask. They will use two different non-invasive ventilation (NIV) masks, each for a minimum of 60 minutes |
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 (5 listed)
- 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
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 |
|---|---|---|
| NIV mask ABridge free face mask | Other | Breathing route assessment: Asleep and on pressure support, Breathing route assessment: Awake and on pressure support |
| NIV mask BFull face mask | Other | Breathing route assessment: Asleep and on pressure support, Breathing route assessment: Awake and on pressure support |
Primary outcome
Breathing route while on and off pressure support (awake)
Time frame: 4 hours
Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.
Breathing route while on pressure support (asleep)
Time frame: 8 hours
Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.
Mask type influence on breathing route (asleep and awake)
Time frame: 12 hours
Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type
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 11 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 NIV mask A and NIV mask B 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 5 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: looking for participants now, as of the sponsor's last update on 11 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 (0064 2102819036, 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?
Breathing route while on and off pressure support (awake) (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 11 May 2025.