Recruiting

Photobiomodulation

Sponsor:

University of Alberta

Code:

NCT05459935

Conditions

Pediatric Sleep Apnea

Obstructive Sleep Apnea

Tonsils Hypertrophy

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

PBM Tonsil Arm

Sham PBM Tonsil Arm

Study Details

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

Study ID

NCT05459935

Start date

Oct 15, 2022

Status verified date

Aug, 2025

Completion date

Jan 6, 2030

Anticipated

Primary completion date

Jul 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PBM Tonsil Arm

Photobiomodulation exposure of hypertrophic tonsils

sham comparator: Tonsil Control Arm

Sham (non-powered) exposure of hypertrophic tonsils

Interventions

PBM Tonsil Arm

exposure of hypertrophic tonsils to photobiomodulation

Sham PBM Tonsil Arm

non-powered exposure of hypertrophic tonsils to photobiomodulation

Primary outcome measure

  • Tonsil Size [ Time Frame: immediately after intervention ]

Central Contacts and Locations

Central contacts

Manuel Lagravere, DDS, PhD

(780) 492-7696manuel@ualberta.ca

Locations

Enjoy Dental

Recruiting

Edmonton, Alberta, Canada, T5X 3N5

Contacts

Enoch Ng, DDS

enoch@ualberta.ca

Manuel Lagravere Vich, DDS

mlagravere@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-08-21.