None listed
Conditions
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.
Interventions
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
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.
Sponsors
Children's Health Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Moderate or severe obstructive sleep apnea on polysomnography Positional obstructive sleep apnea on polysomnography
Exclusion criteria
has an artificial pacemaker
Outcome results
None listed