None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed