Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001006336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
25/07/2026
Date registered
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14/08/2026
Date last updated
Help: Date last updated
14/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/08/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Comparing Heated Humidified High Flow Nasal Cannula and Continuous Positive Airway Pressure Therapy for Children with Obstructive Sleep Apnoea
Scientific title
A Comparison of Heated Humidified High Flow Nasal Cannula and Continuous Positive Airway Pressure Therapy for Obstructive Sleep Apnoea in Children
Additional trial identifiers [1] 318000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Sleep Apnoea 342995 0
Obstructive Sleep Apnoea 342997 0
Condition category
Condition code
Respiratory 339096 339096 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The primary objective of this study is to compare the effectiveness of high flow nasal cannula (HFNC) therapy to gold standard continuous pressure airway pressure (CPAP) therapy in improving polysomnography (PSG) parameters of children with moderate or severe obstructive sleep apnoea (OSA) during a single night study.
The secondary objective of the study is to compare patient tolerance and comfort of HFNC therapy to CPAP therapy.

Children initially underwent a standard diagnostic overnight PSG. Those diagnosed with moderate-to-severe OSA who were not considered suitable candidates for therapeutic surgical intervention, such as adenotonsillectomy, were routinely referred for CPAP therapy as part of standard clinical care. These children would ordinarily return to the sleep laboratory for an overnight CPAP titration study.

Participants who consented to the study were offered an additional overnight heated humidified HFNC titration study prior to their scheduled CPAP titration. HFNC was performed first, followed by the clinically indicated CPAP titration within four weeks. This additional study did not delay or alter routine clinical care, as CPAP titration is typically scheduled two to four weeks following diagnostic PSG because of patient scheduling and sleep laboratory availability.

HFNC was delivered using the Fisher & Paykel AIRVO™ 2 system with warmed, humidified room air administered via appropriately sized nasal cannulae. Nasal prongs were selected to occupy approximately 50% of each nare. Initial flow rates were determined according to participant weight and titrated throughout the overnight study by an experienced sleep clinical nurse technologist to minimise obstructive respiratory events while maintaining participant comfort. Children weighing less than 10 kg commenced at 1 L/kg/min, with flow increased in 1 L/min increments to a maximum of 2 L/kg/min. Participants weighing 10 kg or more commenced at 10 L/min, with flow increased in 5 L/min increments to a maximum of 2 L/kg/min or 60 L/min, whichever was lower.

CPAP titration was subsequently performed during a separate overnight attended PSG according to standard departmental protocols. Therapy was initiated at 4 cmH2O and increased in 1 cmH2O increments until obstructive respiratory events were adequately controlled or the maximum therapeutic pressure was reached. All intervention procedures were undertaken with close clinical supervision at all times within the sleep lab. All PSG studies were scored according to American Academy of Sleep Medicine paediatric scoring criteria and interpreted independently by sleep physicians blinded to the results of the alternate treatment study. Participant- or parent-reported comfort questionnaires were completed following each intervention to assess treatment tolerability and preference.
Intervention code [1] 334875 0
Treatment: Devices
Description of the comparator or control
The control group was the gold standard CPAP used post diagnosis of OSA in children. HFNC therapy intervention occurred concurrent to the CPAP study (provided participants were able to tolerate CPAP) in a sleep lab setting under direct clinical care and close monitoring. There was no seperate control set of participants, the same participants serve as both the intervention and control group.
Control group
Active

Outcomes
Primary outcome [1] 346346 0
A change in severity of OSA in children with moderate to severe OSA during the HFNC single night study.
Timepoint [1] 346346 0
Assessed after Baseline PSG, post HFNC treatment night PSG and CPAP treatment night PSG
Secondary outcome [1] 465490 0
A difference in patient and parent/caregiver reported comfort levels and tolerance between HFNC and CPAP treatments.
Timepoint [1] 465490 0
Post HFNC and CPAP study night

Eligibility
Key inclusion criteria
All children under 16 years of age with baseline PSG diagnosed moderate or severe OSA in whom a CPAP trial is planned by a sleep physician. Informed consent in accordance with the institutional policies must be signed by the patient's legally authorised guardian acknowledging written consent to join the study.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
-Children with a current upper respiratory tract infection
-Children who are receiving oxygen therapy
-Children with OSA and co-existing central sleep apnoea with a central apnoea/hypopnea index > 5 events per hour.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/12/2019
Date of last participant enrolment
Anticipated
Actual
1/03/2024
Date of last data collection
Anticipated
Actual
28/03/2024
Sample size
Target
58
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 29914 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 46271 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 322547 0
Hospital
Name [1] 322547 0
Children's Health Queensland SERTA
Country [1] 322547 0
Australia
Funding source category [2] 322563 0
Commercial sector/Industry
Name [2] 322563 0
Fisher&Paykel
Country [2] 322563 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 325469 0
None
Name [1] 325469 0
Address [1] 325469 0
Country [1] 325469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321028 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 321028 0
Ethics committee country [1] 321028 0
Australia
Date submitted for ethics approval [1] 321028 0
25/09/2018
Approval date [1] 321028 0
21/01/2019
Ethics approval number [1] 321028 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152422 0
A/Prof Jasneek Kaur Chawla
Address 152422 0
Department of Paediatric Respiratory and Sleep Medicine, Queensland Children's Hospital, 501 Stanley St, South Brisbane, 4101, Queensland
Country 152422 0
Australia
Phone 152422 0
+61 452 662 105
Fax 152422 0
Email 152422 0
[email protected]
Contact person for public queries
Name 152423 0
Isha Shin
Address 152423 0
Child Health Research Centre (The University of Queensland), Centre for Children's Health Research, 62 Graham Street, South Brisbane, 4101, Queensland
Country 152423 0
Australia
Phone 152423 0
+61 457 303 067
Fax 152423 0
Email 152423 0
[email protected]
Contact person for scientific queries
Name 152424 0
Jasneek Kaur Chawla
Address 152424 0
Department of Paediatric Respiratory and Sleep Medicine, Queensland Children's Hospital, 501 Stanley St, South Brisbane, 4101, Queensland
Country 152424 0
Australia
Phone 152424 0
+61 7 3068 2300
Fax 152424 0
Email 152424 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
6 months after primary publication of this study takes place

To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email to principal investigator - [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.