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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
12/11/2024

Titles & IDs
Public title
Assessment of Breathing Pattern During NIV
Scientific title
Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. an Experimental Study.
Secondary ID [1] 0 0
U1111-1308-1838
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD (Chronic Obstructive Pulmonary Disease) 0 0
Obesity Hypoventilation Syndrome (OHS) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Breathing route while on and off pressure support (awake)
Timepoint [1] 0 0
4 hours
Primary outcome [2] 0 0
Breathing route while on pressure support (asleep)
Timepoint [2] 0 0
8 hours
Primary outcome [3] 0 0
Mask type influence on breathing route (asleep and awake)
Timepoint [3] 0 0
12 hours

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06682286
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Good, Medical degree
Address 0 0
Middlemore Hospital, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Valeria Mereacre, PhD Physiology
Address 0 0
Country 0 0
Phone 0 0
0064 2102819036
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06682286