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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
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Scientific title
Pilot Study of Paediatric Positional OSA Treatment for Children Aged 6 to 18 years
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Secondary ID [1]
312782
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Nil Known
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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:
obstructive sleep apnea
334837
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Condition category
Condition code
Respiratory
331395
331395
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329310
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Obstructive sleep apnea
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Assessment method [1]
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Obstructive apnea hypopnea index, as determined by polysomnography performed in an accredited paediatric sleep laboratory
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Timepoint [1]
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Baseline and 6 weeks to 6 months after treatment initiation
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Secondary outcome [1]
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Sleep related symptoms
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Assessment method [1]
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Paediatric Sleep Questionnaire
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Timepoint [1]
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Baseline and 6 weeks to 6 months after treatment initiation
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Eligibility
Key inclusion criteria
Moderate or severe obstructive sleep apnea on polysomnography
Positional obstructive sleep apnea on polysomnography
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Minimum age
6
Years
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Maximum age
18
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
has an artificial pacemaker
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2025
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Actual
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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
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Queensland
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Children's Health Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319487
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Address [1]
319487
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Country [1]
319487
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
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http://www.childrens.health.qld.gov.au/research/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/09/2024
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Approval date [1]
315877
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Ethics approval number [1]
315877
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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.
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Trial website
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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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Dr Ajay Kevat
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Address
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Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
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Country
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Australia
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Phone
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+61 7 3068 1793
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ajay Kevat
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Address
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Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
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Country
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Australia
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Phone
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+61 7 3068 2300
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Fax
136067
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ajay Kevat
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Address
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Queensland Children's Hospital, Level 5a, 501 Stanley St, South Brisbane, Queensland 4101
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Country
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Australia
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Phone
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+61 7 3068 1793
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Fax
136068
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Email
136068
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Privacy and confidentiality
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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.
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