Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000465550p
Ethics application status
Not yet submitted
Date submitted
23/03/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Paediatric Obstructive Sleep Apnoea (OSA) Screening Triple Test (POSTT) Study: Validation of a novel home delivered paediatric OSA screening test.
Scientific title
The Paediatric Obstructive Sleep Apnoea (OSA) Screening Triple Test (POSTT) Study: Validation of a novel home delivered paediatric OSA screening test.
Secondary ID [1] 311616 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POSTT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Obstructive Sleep Apnoea 333328 0
Paediatric sleep disordered breathing 333329 0
Condition category
Condition code
Respiratory 330016 330016 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The proposed intervention is a home-based POSTT consisting of nocturnal pulse oximetry, a validated PSQ, and video-assessment of tonsillar size. This is available as a standalone kit that can be mailed to study participants.

Participants will receive POSTT kits (already built and ready for testing) containing a sleep diary, pulse oximetry unit, disposable accessories, and instruction manual for parents to set up and perform PO and record significant events in the sleep diary. This instruction video and manual has been specifically designed and developed for this research trial.

a. Home Nocturnal Pulse Oximetry (PO): PO will be performed over one night in participants’ homes: This involves a small finger oximetry sensor and oximetry device (TGA Approved for paediatric use) which is worn over the course of one night's sleep. Parents/carers will also be required to complete a sleep diary notating the child's sleep symptoms and other night-time events. The Oximetry will be reported by a researcher sleep physician according to McGill scoring system for the presence and severity of obstructive sleep apnoea, namely Normal/inconclusive, Mild Obstructive Sleep Apnoea, moderate Obstructive Sleep Apnoea, severe Obstructive Sleep Apnoea.
b. Paediatric Sleep Questionnaire (PSQ): The PSQ consists of 22 symptom items encompassing 4 domains: sleep-related breathing, snoring, daytime somnolence, and behaviour. The overall score is calculated as a proportion of positive answers with a score greater or equal to 0.33 considered predictive for OSA. In this study, participants will receive a PSQ as part of the POSTT kit.
c. Video Study: In this study, participants will receive a smart-phone attached, single-use LED-lluminated (commercially available) tongue depressor which attaches to a smartphone video device (TGA approved) plus instructions for parents on how to record a brief video of their child’s oral cavity (as little as 5 seconds will be adequate). This recording will be remotely reviewed by a doctor to grade tonsil size from 0 to IV according to the Brodsky grading scale. With a positive result being a score of III or IV, and a negative result being I or II.

Whilst the kit is in the possession of the participant and family, they may directly contact the study research assistance via mobile phone call or text, for technical support - one 5 minute call per evening of study.

If once the kit is returned, any component of the triple test is deemed inadequate for reporting/scoring, it will be returned to the family for repeat testing within 1 week, and prior to the family undertaking the Gold standard Polysomnography test. A maximum of 1 repeat test will be offered/performed.
Intervention code [1] 328256 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator/Control Treatment: The Gold Standard test or 'control' treatment is the Polysomnography. It will be conducted over one night in a sleep laboratory in the presence of trained technical staff and under the supervision of a sleep physician. This involves continuous recording of multiple physiological variables (e.g., EEG, ECG, PO, digital video recording, etc.). If a single night study is deemed to have inadequate data or poor quality, then a second night’s study will be offered/performed. It will be reported according to standard reporting criteria and the presence and severity of any obstructive sleep apnoea will be reported. This study will be performed within 4 weeks of the POSTT which is the comparator, with no minimum time between the two studies.
Control group
Active

Outcomes
Primary outcome [1] 337770 0
Sensitivity and Specificity of POSTT for the prediction of moderate or severe Obstructive Sleep Apnoea will be determined.
Timepoint [1] 337770 0
POSTT completed on Day 1, and overnight Polysomnography completed within the next 4 weeks.
Secondary outcome [1] 433278 0
POSTT test repeat proportion
Timepoint [1] 433278 0
Once patient has completed POSTT kit
Secondary outcome [2] 433279 0
Test completion proportion
Timepoint [2] 433279 0
Once all patients have completed POSTT kits.
Secondary outcome [3] 433280 0
Patient Satisfaction
Timepoint [3] 433280 0
Within 1 week of completing the POSTT and Polysomnography, the Net Promoter score (NPS); for the POSTT and Polysomnography will be calculated

Eligibility
Key inclusion criteria
a) Target Population: Australian children aged 2-16 years and at least one parent/guardian
b) Sample Populations:
- Patients, who have already been referred for PSG and fit inclusion criteria, will be recruited from each participating sleep centre.
c) Study participants will be considered eligible for inclusion if they are aged between 2-16 years at the time of recruitment, and able to complete the POSTT within 4 weeks of PSG.
Minimum age
2 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria 1: Based on studies showing reduced accuracy of pulse oximetry testing in these populations, children with the following conditions will be excluded from the study:
a. Neuromuscular disease,
b. Congenital syndromes (e.g. Trisomy 21),
c. Congenital heart diseases,
d. Chronic lung disease requiring oxygen therapy,
e. Previous trauma/burns to airway/face/neck,
f. Weight <3rd or >95th centile for age

Exclusion Criteria 2: Previous adenotonsillectomy (this renders tonsillar size component of index test non-contributory).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
129
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD,VIC

Funding & Sponsors
Funding source category [1] 315924 0
Charities/Societies/Foundations
Name [1] 315924 0
The Passe and Williams Foundation
Country [1] 315924 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318323 0
None
Name [1] 318323 0
Address [1] 318323 0
Country [1] 318323 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314772 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314772 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314772 0
Australia
Date submitted for ethics approval [1] 314772 0
06/05/2024
Approval date [1] 314772 0
Ethics approval number [1] 314772 0

Summary
Brief summary
Obstructive sleep apnoea (OSA) has serious negative impacts to the physical health, mental health, and cognitive function and development of children. Unfortunately, OSA is quite common and is reported to occur between 1-6% of children. However, currently, the gold standard for OSA assessment (a sleep study or polysomnography (PSG)) is expensive and difficult to access. The limited access to PSG testing leads to unnecessary risk for these children, as it often delays in treatment, and/or results in an incomplete assessment prior to surgeries like adenotonsillectomy. However, a novel postage delivered and home conducted kit may be able to reduce these issues. The Paediatric OSA Screening Triple Test (POSTT) is TGA approved and includes an overnight oximetry device, a validated sleep questionnaire, and video tonsil assessment tool. This proposed research will compare the novel POSTT kit to PSG and determine the diagnostic accuracy, real-world feasibility, and patient satisfaction and preference. We hypothesise that the POSTT kit will demonstrate to be as accurate and more feasible than PSG. If the hypothesise is correct, the novel kit will allow for an increase in access to care, especially for regional and rural patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132674 0
A/Prof Paul Paddle
Address 132674 0
Monash Health, Department of Otolaryngology, Head and Neck Surgery: 823-865 Centre Road, Bentleigh East, Victoria 3165
Country 132674 0
Australia
Phone 132674 0
+61 447558499
Fax 132674 0
Email 132674 0
paulpaddle@me.com
Contact person for public queries
Name 132675 0
Paul Paddle
Address 132675 0
Monash Health, Department of Otolaryngology, Head and Neck Surgery: 823-865 Centre Road, Bentleigh East, Victoria 3165
Country 132675 0
Australia
Phone 132675 0
+61 447558499
Fax 132675 0
Email 132675 0
paulpaddle@me.com
Contact person for scientific queries
Name 132676 0
Paul Paddle
Address 132676 0
Monash Health, Department of Otolaryngology, Head and Neck Surgery: 823-865 Centre Road, Bentleigh East, Victoria 3165
Country 132676 0
Australia
Phone 132676 0
+61 447558499
Fax 132676 0
Email 132676 0
paulpaddle@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.