Enjoy Dental
Edmonton, Alberta, T5X 3N5, Canada
Location status: Recruiting
NCT Number: NCT05459935
Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea.
The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children
The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting.
The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, T5X 3N5, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exposure of hypertrophic tonsils to photobiomodulation
Other names: Fotona Lightwalker AT S
non-powered exposure of hypertrophic tonsils to photobiomodulation
Other names: Fotona Lightwalker AT S - non-powered
Time frame: immediately after intervention
Tonsil size grading (Brodsky score): 0-4, 0 being not present 4 being restrictive to entire airway. Lower scores are better. Each integer represents 25% obstruction of airway (0 being not visible, 1 being 0-25%, 2 being 25-50%, 3 being 50-75%, 4 being 75-100%). There is no abbreviated scale title.
Time frame: Next Day (next night)
Comparisons of before and after AHI score by portable sleep testing device
Time frame: night after, per quarter after for 1 year
Comparisons of before and after PSQ (pediatric sleep questionnaire) scores
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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