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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06682286
Registration number
NCT06682286
Ethics application status
Date submitted
5/11/2024
Date registered
12/11/2024
Date last updated
11/05/2025
Titles & IDs
Public title
Assessment of Breathing Pattern During NIV
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Scientific title
Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study
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Secondary ID [1]
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U1111-1308-1838
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD (Chronic Obstructive Pulmonary Disease)
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Obesity Hypoventilation Syndrome (OHS)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Respiratory
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Other respiratory disorders / diseases
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NIV mask A
Other interventions - NIV mask B
No intervention: Breathing route assessment: Awake and off pressure support - Breathing route will be recorded in awake participants without the use of NIV for approximately 30 min.
Experimental: Breathing route assessment: Awake and on pressure support - 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.
Experimental: Breathing route assessment: Asleep and on pressure support - 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
Other interventions: NIV mask A
Bridge free face mask
Other interventions: NIV mask B
Full face mask
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Breathing route while on and off pressure support (awake)
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Assessment method [1]
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Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.
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Timepoint [1]
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4 hours
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Primary outcome [2]
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Breathing route while on pressure support (asleep)
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Assessment method [2]
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Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.
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Timepoint [2]
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8 hours
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Primary outcome [3]
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Mask type influence on breathing route (asleep and awake)
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Assessment method [3]
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Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type
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Timepoint [3]
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12 hours
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Fisher and Paykel Healthcare
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06682286
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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William Good, Medical degree
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Address
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Middlemore Hospital, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Valeria Mereacre, PhD Physiology
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Address
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Country
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Phone
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0064 2102819036
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Fax
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Email
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val.mereacre@fphcare.co.nz
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06682286
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