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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
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Scientific title
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
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Secondary ID [1]
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U1111-1259-4797
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Secondary ID [2]
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CIA-279
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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:
Sleep-disordered Breathing
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Hypercapnia
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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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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Transcutaneous carbon dioxide
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Assessment method [1]
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The change in transcutaneous carbon dioxide from the 3 different baselines to the transcutaneous carbon dioxide during non-REM sleep on CPAP on the same study night. Three different values will be determined for each mask.
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Timepoint [1]
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1 day (From baseline to the end of the study night)
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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.
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Minimum age
18
Years
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Maximum age
100
Years
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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
- 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
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Study design
Purpose of the study
Treatment
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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
Terminated
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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
7/07/2021
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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
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Actual
5/07/2023
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Sample size
Target
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Accrual to date
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Final
40
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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
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04926805
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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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Andy Veale, Dr
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Address
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New Zealand Respiratory and Sleep Insitute
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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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Address
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04926805
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