Photobiomodulation for Pediatric Hypertrophic Tonsils

Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation

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 Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Pediatric Sleep Apnea; Tonsils Hypertrophy
• Intervention / Treatment: Device: PBM Tonsil Arm; Device: Sham PBM Tonsil Arm

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Lagravere, DDS, PhD; Phone Number: (780) 492-7696; Email: manuel@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5X 3N5
      • Recruiting
      • Enjoy Dental
      • Contact: Enoch Ng, DDS; Email: enoch@ualberta.ca
      • Contact: Manuel Lagravere Vich, DDS; Email: mlagravere@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBM Tonsil Arm; Photobiomodulation exposure of hypertrophic tonsils	Device: PBM Tonsil Arm; exposure of hypertrophic tonsils to photobiomodulation; Other Names: Fotona Lightwalker AT S
Sham Comparator: Tonsil Control Arm; Sham (non-powered) exposure of hypertrophic tonsils	Device: Sham PBM Tonsil Arm; non-powered exposure of hypertrophic tonsils to photobiomodulation; Other Names: Fotona Lightwalker AT S - non-powered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tonsil Size	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.	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI Score	Comparisons of before and after AHI score by portable sleep testing device	Next Day (next night)
Questionnaire Improvement	Comparisons of before and after PSQ (pediatric sleep questionnaire) scores	night after, per quarter after for 1 year

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): January 6, 2030

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertrophy; Apnea
• Other Study ID Numbers: 00103330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes