RECRUITING Not applicable ClinicalTrials.gov

Photobiomodulation for Pediatric Hypertrophic Tonsils

Sponsor: University of Alberta • ClinicalTrials.gov ID: NCT05459935

Registry updated: 2026-09-15

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

PBM Tonsil Arm (Device)
exposure of hypertrophic tonsils to photobiomodulation
Sham PBM Tonsil Arm (Device)
non-powered exposure of hypertrophic tonsils to photobiomodulation

Eligibility criteria

Inclusion Criteria: * Brodsky visually graded tonsils 3/4 * patient must assent, parent must consent, to all pre and post follow up including sleep testing * patient and parent must agree to normal referral protocols regardless of participation within this study or not Exclusion Criteria: * visual indication of cancerous growth * currently under treatment (pharmacologic, other) for hypertrophic tonsils * already scheduled for surgical intervention of hypertrophic tonsils

Conditions

Pediatric Sleep Apnea Obstructive Sleep Apnea Tonsils Hypertrophy

Locations

Enjoy Dental — Edmonton, Alberta, Canada

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment