Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000554460p
Ethics application status
Not yet submitted
Date submitted
12/12/2024
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of limited channel home sleep studies in children.
Scientific title
Clinical utility of Level 3 (limited channel) sleep studies for children in paediatric sleep medicine
Secondary ID [1] 313562 0
MRF2035688
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea (OSA) 336070 0
Continuous Positive Airways Pressure (CPAP) 336071 0
Condition category
Condition code
Public Health 332794 332794 0 0
Health service research
Respiratory 332793 332793 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Limited channel sleep studies (L3 studies) will be undertaken in the home, in addition to the clinically-indicated laboratory-based (L1 PSG) sleep study which is undertaken in the hospital environment. The L3 study will occur ahead of, and within 4 weeks of the L1 PSG.

The focus of this project, is to determine the appropriate balance between the relative ease of use for L3 (home) studies and detailed evaluation of how effective they are for assessment of respiratory sleep disorders in children. We will study a broad population of children referred for evaluation and treatment of respiratory sleep disorders. The project will be conducted in two stages:
• Phase 1: Collaboration with consumers to co-design specifics of the conduct of level 3 studies. These studies can be set up by sleep scientists or parents in the hospital or a child’s home.
Focus groups will be facilitated by an experienced qualitative researcher. Six to eight parents of children who have undergone L1 (laboratory) PSG will be invited to participate in two, online, 1-hour focus groups held over the course of a month. The focus groups will include a sleep scientist who can answer questions on the study processes and the different options being offered. Families will be offered the option of trialling an L3 home study with their child, and they will be asked to evaluate and provide feedback on their order of preference for the different methods of delivering the L3 (home) studies. Options include
A group of six to eight sleep scientists will be involved in a separate focus group meeting to evaluate their experience of, and preferences for the L3 home sleep study delivery.
A final focus group will include parents and sleep scientists to determine a consensus between families and sleep scientists on the best method for setting up and delivering the L3 home studies.

• Phase 2a:will commence approximately 6 months later. Limited channel (L3) sleep studies will be offered to all children on waiting lists for L1 PSG, using the consensus method determined in Phase 1.
The home (L3) study will be conducted for a single night, within one month prior to the child’s scheduled L1 PSG (with an option for repeating the study on a second night if the first attempt fails). Clinical management will follow the clinicians recommendation after they review the L1 PSG. Primary analysis will compare the accuracy of the L3 (limited channel home) study for evaluating sleep disordered breathing in children, compared to the standard laboratory-based L1 PSG.

The study goal is to determine the diagnostic accuracy of home L3 studies compared to L1 PSG, and to obtain feedback from families on their experience with each form of monitoring using both qualitative and quantitative methods. No specific device has been selected for trial, with any device suitable providing it can record the necessary channels by recording:
- Airflow
- oxygen saturation (oxygen saturation monitor)
- respiratory effort (most commonly plethysmography bands)
- ECG/ heart rate
The study outcomes will be analysed independently of the clinical L1 PSG. Clinicians blinded to the alternative study will make treatment or intervention recommendations on the basis of both the L1 PSG and the L3 studies. The primary study outcome will be comparison of the clinician-recommended treatment or intervention made on the basis of the L3 study compared to the clinician-recommended treatment or intervention made on the basis of the L1 PSG.

Phase 2b: The final phase will be an economic evaluation of home L3 studies in comparison to L1 PSG. by collecting relevant healthcare costs associated with children on waiting lists for L1 PSG with relevant cost analyses. This requires that participating families complete relevant questionnaires and consent to collection of health utilisation data for their child.
Intervention code [1] 330271 0
Treatment: Devices
Intervention code [2] 330153 0
Diagnosis / Prognosis
Comparator / control treatment
A single night, laboratory-based polysomnography (L1 PSG). This test will be scheduled according to clinical need, and for the study will be undertaken within 1 month of the home-based L3 study. L1 PSG will be undertaken according to the requirements of the standard medicare item number.
This includes that:
(a) the patient is referred by a medical practitioner; and
(b) the necessity for the investigation is determined by a qualified paediatric sleep medicine practitioner before the investigation; and
(c) there is continuous monitoring of oxygen saturation and breathing using a multi channel polygraph, and recordings of the following are made, in accordance with current professional guidelines:
(i) airflow;
(ii) continuous EMG;
(iii) ECG;
(iv) EEG (with a minimum of 4 EEG leads or, in selected investigations, a minimum of 6 EEG leads);
(v) EOG;
(vi) oxygen saturation;
(vii) respiratory movement of rib and abdomen (whether movement of rib is recorded separately from, or together with, movement of abdomen);
(viii) measurement of carbon dioxide (either end tidal or transcutaneous); and
(d) a sleep technician, or registered nurse with sleep technology training, is in continuous attendance under the supervision of a qualified paediatric sleep medicine practitioner; and
(e) polygraphic records are:
(i) analysed (for assessment of sleep stage, and maturation of sleep indices, arousals, respiratory events and assessment of clinically significant alterations in heart rate and body movement) with manual scoring, or manual correction of computerised scoring in epochs of not more than 1 minute; and
(ii) stored for interpretation and preparation of a report; and
(f) interpretation and report are provided by a qualified paediatric sleep medicine practitioner based on reviewing the direct original recording of polygraphic data from the patient
Control group
Active

Outcomes
Primary outcome [1] 340136 0
The proportion of children with concordant treatment recommendations based on their L3 and L1 studies (i.e., percentage agreement).
Timepoint [1] 340136 0
Any treatment recommendation based on the laboratory-based L1 PSG sleep study will be undertaken according to normal clinical timelines. This will not affect, or be influenced by, the conduct of or outcomes from the research study evaluating the home-based L3 study. The evaluation of the home-based L3 study outcomes will be undertaken as a component of the data analysis at the conclusion of the research study.
Secondary outcome [1] 443702 0
Economic evaluation
Timepoint [1] 443702 0
At the time of study analysis after all L1 and L3 data have been collected
Secondary outcome [2] 442921 0
Success rates for of L1 and L3 studies
Timepoint [2] 442921 0
At study analysis after all L1 and L3 data has been collected
Secondary outcome [3] 442919 0
The diagnostic accuracy (quantified with percentage agreement, Sn, Sp, PPV, NPV) of L3 compared to L1 sleep studies for the diagnosis of OSA.
Timepoint [3] 442919 0
At the time of final study data analysis after all L1 and L3 data has been collected. (These outcomes will not affect the clinical recommendations made for treatment, based on the clinically-recommended L1 PSG study).

Eligibility
Key inclusion criteria
Children aged 'greater than or equal to 2 years and less than or equal to 17 years who are on the waiting list for L1 PSG for investigation of suspected OSA or treatment monitoring of previously diagnosed OSA
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- parents with inadequate English language skills for consent, questionnaires and instructions
- a lack of access to a safe setting for the L3 study
- a guardian who is reluctant or unable to supervise the study
- PSG requested for investigation of non-respiratory sleep disorders.

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is based primarily on practical considerations. We expect to recruit approximately 300 children, and the outcome of interest is the percentage of children for whom the L3 study is conducted without failure and results in the same treatment recommendation as their L1 PSG. A study of at least 250 children has more than 90% power at 5% one-sided alpha to rule out a rate of 85% or less if the true percentage is 87% or higher. This will estimate the percentage achieving the outcome with a 95% confidence interval of maximum width ±6.2% (this occurs when the observed percentage equals 50%, if the observed percentage is higher the CI will be narrower).
Outcomes to be assessed:
- % Agreements
- Sensitivity (Sn), specificity (Sp), positive predictive value (PPV) and negative predictive values (NPV)
- Generalised linear models (including mixed effects as appropriate)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 27409 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 27408 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 27411 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 27410 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 43523 0
3168 - Clayton
Recruitment postcode(s) [2] 43521 0
2145 - Westmead
Recruitment postcode(s) [3] 43522 0
3052 - Parkville
Recruitment postcode(s) [4] 43524 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 318025 0
Government body
Name [1] 318025 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 318025 0
Australia
Primary sponsor type
Government body
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320370 0
None
Name [1] 320370 0
Address [1] 320370 0
Country [1] 320370 0
Other collaborator category [1] 283326 0
University
Name [1] 283326 0
The University of Sydney
Address [1] 283326 0
Country [1] 283326 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316683 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 316683 0
Ethics committee country [1] 316683 0
Australia
Date submitted for ethics approval [1] 316683 0
09/06/2025
Approval date [1] 316683 0
Ethics approval number [1] 316683 0

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

Contacts
Principal investigator
Name 138654 0
Prof Karen Waters
Address 138654 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 138654 0
Australia
Phone 138654 0
+61 2 9845 3437
Fax 138654 0
Email 138654 0
[email protected]
Contact person for public queries
Name 138655 0
Karen Waters
Address 138655 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 138655 0
Australia
Phone 138655 0
+61 2 9845 3437
Fax 138655 0
Email 138655 0
[email protected]
Contact person for scientific queries
Name 138656 0
Karen Waters
Address 138656 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 138656 0
Australia
Phone 138656 0
+61 2 9845 3437
Fax 138656 0
Email 138656 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:
• Scientific investigators

Conditions for requesting access:
• -

What individual participant data might be shared?
• sleep study outcomes

What types of analyses could be done with individual participant data?
• Secondary or additional analyses

When can requests for individual participant data be made (start and end dates)?
From:
For 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By email application to primary investigator ([email protected]), and review of the request by the investigator group.

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.