Using laser light therapy to treat enlarged tonsils in children
Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
This study is testing if a special laser light therapy can help children with enlarged tonsils breathe better during sleep, as an alternative to surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05459935 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of photobiomodulation (PBM) therapy as a non-invasive treatment for pediatric obstructive sleep apnea caused by hypertrophic tonsils. The study compares the effects of PBM on tonsils with a sham treatment to evaluate its efficacy in improving breathing during sleep. Participants will undergo sleep testing before and after the treatment to assess changes in their condition. The goal is to provide a safer alternative to surgical removal of tonsils and adenoids, which carries risks and does not always guarantee success.
Who should consider this trial
Good fit: Ideal candidates are children with Brodsky graded tonsils 3/4 who are experiencing obstructive sleep apnea.
Not a fit: Patients with visual indications of cancerous growth or those already scheduled for surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, non-invasive option for children suffering from obstructive sleep apnea due to enlarged tonsils.
How similar studies have performed: While PBM has shown some success in treating adult snoring and obstructive sleep apnea, its application in pediatric cases is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- Enjoy Dental — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Manuel Lagravere, DDS, PhD
- Email: manuel@ualberta.ca
- Phone: (780) 492-7696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.