Photobiomodulation for Pediatric Hypertrophic Tonsils

NCT05459935 | Recruiting FDA Device

• 1 other identifier: 00103330
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Sleep Apnea; Obstructive Sleep Apnea; Tonsils Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• AHI Score

  Next Day (next night)

• Questionnaire Improvement

  night after, per quarter after for 1 year

Study Arms (2)

PBM Tonsil Arm

EXPERIMENTAL

Photobiomodulation exposure of hypertrophic tonsils

Device: PBM Tonsil Arm

Tonsil Control Arm

SHAM COMPARATOR

Sham (non-powered) exposure of hypertrophic tonsils

Device: Sham PBM Tonsil Arm

Interventions

PBM Tonsil Arm DEVICE

exposure of hypertrophic tonsils to photobiomodulation

Also known as: Fotona Lightwalker AT S

PBM Tonsil Arm

Sham PBM Tonsil Arm DEVICE

non-powered exposure of hypertrophic tonsils to photobiomodulation

Also known as: Fotona Lightwalker AT S - non-powered

Tonsil Control Arm

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• visual indication of cancerous growth
• currently under treatment (pharmacologic, other) for hypertrophic tonsils
• already scheduled for surgical intervention of hypertrophic tonsils

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Enjoy Dental

Edmonton, Alberta, T5X 3N5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Manuel Lagravere, DDS, PhD

CONTACT

(780) 492-7696; manuel@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham intervention (nonactivated/unpowered phototherapy intervention)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: July 15, 2022
• Study Start: October 15, 2022
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): January 6, 2030
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)