Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT05459935
Brief Summary:
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.
Study:
NCT05459935
Study Brief:
Protocol Section:
NCT05459935