NCT05459935 Photobiomodulation for Pediatric Hypertrophic Tonsils
| NCT ID | NCT05459935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Pediatric Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2026-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2022-10-15 with a primary completion date of 2026-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05459935 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Pediatric Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05459935 currently recruiting?
Yes, NCT05459935 is actively recruiting participants. Contact the research team at manuel@ualberta.ca for enrollment information.
Where is the NCT05459935 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05459935 clinical trial?
NCT05459935 is sponsored by University of Alberta. The trial plans to enroll 64 participants.