Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04926805




Registration number
NCT04926805
Ethics application status
Date submitted
2/06/2021
Date registered
15/06/2021
Date last updated
12/07/2023

Titles & IDs
Public title
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Scientific title
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Secondary ID [1] 0 0
U1111-1259-4797
Secondary ID [2] 0 0
CIA-279
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep-disordered Breathing 0 0
Hypercapnia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CPAP with Mask A
Treatment: Devices - CPAP with Mask B

Experimental: Mask A - Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only.

Active Comparator: Mask B - Overnight CPAP using the participant's usual pressure settings and using Mask B. One night only.


Treatment: Devices: CPAP with Mask A
CPAP mask

Treatment: Devices: CPAP with Mask B
CPAP mask
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Transcutaneous carbon dioxide
Timepoint [1] 0 0
1 day (From baseline to the end of the study night)

Eligibility
Key inclusion criteria
- Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)

- Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or
more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of
more.

- Provide written informed consent

- Already use a full (oronasal) face mask for CPAP

- Willing to have a venous blood sample taken during the pre-screening visit.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of sleep apnea on CPAP:

- Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or

- If the AHI has not already decreased by 50 percent or more from pre-CPAP to with
CPAP.

- Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.

- Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less
than fifty percent of predicted, at the screening visit.

- Have poorly controlled asthma or changing asthma symptoms.

- Nasal obstruction

- Do not fit Mask A or Mask B

- Agitation or psychological illness

Study design
Purpose of the study
Treatment
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/07/2023
Sample size
Target
Accrual to date
Final
40
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
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to
the upper airways to provide respiratory support. Two types of NIV can be delivered;
continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two
pressures for inhalation and exhalation.

This investigation is designed to physiologically evaluate the performance of a NIV mask,
Mask A, compared to a standard NIV mask, Mask B on CPAP therapy.

People with sleep disordered breathing who have chronic hypercapnia, and are already
receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on
Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded.

Parameters will be recorded during three baselines at the beginning of each evening and
throughout the night when participants are asleep. The three baselines are:

1. participant awake with normal breathing (not on CPAP),

2. participant awake and on CPAP, and

3. participant asleep on CPAP in REM-sleep (rapid eye movement sleep).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04926805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andy Veale, Dr
Address 0 0
New Zealand Respiratory and Sleep Insitute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04926805