Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001082594p
Ethics application status
Not yet submitted
Date submitted
19/08/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of Paediatric Positional Obstructive Sleep Apnoea (OSA) Treatment
Scientific title
Pilot Study of Paediatric Positional OSA Treatment for Children Aged 6 to 18 years
Secondary ID [1] 312782 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 334837 0
Condition category
Condition code
Respiratory 331395 331395 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is wearing of a Patient Positioning Sensor device, worn overnight for sleep, around the neck to or body, on a daily basis for 6 weeks to 6 months, until completion of repeat polysomnography (sleep study). The device vibrates when the wearer is sleeping on their back, and stops vibrating once the wearer changes their sleep position.

Participants/parents/caregivers will receive an introduction and training on how to use the sensor, in the form of a one-on-one face-to-face 20-min consultation at the beginning of the intervention period, by a qualified paediatric sleep physician, scientist or nurse who will provide this i.e. administer the intervention. A paediatric sleep physician will have oversight and responsibility as Principal Investigator.

Adherence (device use) will be monitored using inbuilt adherence monitoring from the device (device analytics), which can be downloaded and printed out.
Intervention code [1] 329310 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339139 0
Obstructive sleep apnea
Timepoint [1] 339139 0
Baseline and 6 weeks to 6 months after treatment initiation
Secondary outcome [1] 438746 0
Sleep related symptoms
Timepoint [1] 438746 0
Baseline and 6 weeks to 6 months after treatment initiation

Eligibility
Key inclusion criteria
Moderate or severe obstructive sleep apnea on polysomnography
Positional obstructive sleep apnea on polysomnography
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
has an artificial pacemaker

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317216 0
University
Name [1] 317216 0
University of Queensland
Country [1] 317216 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland
Address
Country
Australia
Secondary sponsor category [1] 319487 0
None
Name [1] 319487 0
Address [1] 319487 0
Country [1] 319487 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315877 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315877 0
http://www.childrens.health.qld.gov.au/research/human-research-ethics-committee
Ethics committee country [1] 315877 0
Australia
Date submitted for ethics approval [1] 315877 0
30/09/2024
Approval date [1] 315877 0
Ethics approval number [1] 315877 0

Summary
Brief summary
Positional obstructive sleep apnea (OSA) is a subtype of OSA in which the obstructive problem occurs when the child sleeps supine (on their back).

We hypothesise that children with positional OSA will have less obstructive problems/events and less sleep related symptoms identified on their sleep study (polysomnography) when wearing a positional OSA device as a treatment, compared to without this device.

We are aiming to conduct a pilot study to begin with, recruiting twelve participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136066 0
Dr Ajay Kevat
Address 136066 0
Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
Country 136066 0
Australia
Phone 136066 0
+61 7 3068 1793
Fax 136066 0
Email 136066 0
[email protected]
Contact person for public queries
Name 136067 0
Ajay Kevat
Address 136067 0
Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
Country 136067 0
Australia
Phone 136067 0
+61 7 3068 2300
Fax 136067 0
Email 136067 0
[email protected]
Contact person for scientific queries
Name 136068 0
Ajay Kevat
Address 136068 0
Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
Country 136068 0
Australia
Phone 136068 0
+61 7 3068 1793
Fax 136068 0
Email 136068 0
[email protected]

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


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.