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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

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)
Assessment method [1] 0 0
Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.
Timepoint [1] 0 0
4 hours
Primary outcome [2] 0 0
Breathing route while on pressure support (asleep)
Assessment method [2] 0 0
Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.
Timepoint [2] 0 0
8 hours
Primary outcome [3] 0 0
Mask type influence on breathing route (asleep and awake)
Assessment method [3] 0 0
Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type
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
1/01/2025
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
val.mereacre@fphcare.co.nz
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