Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05459935

Photobiomodulation for Pediatric Hypertrophic Tonsils

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enjoy Dental

Edmonton, Alberta, T5X 3N5, Canada

Location status: Recruiting

Location contact

Enoch Ng, DDS

CONTACT

[email protected]

Manuel Lagravere Vich, DDS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBM Tonsil Arm

Device

exposure of hypertrophic tonsils to photobiomodulation

Other names: Fotona Lightwalker AT S

Sham PBM Tonsil Arm

Device

non-powered exposure of hypertrophic tonsils to photobiomodulation

Other names: Fotona Lightwalker AT S - non-powered

Primary outcomes

  1. Tonsil Size

    Time frame: immediately after intervention

    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.

Secondary outcomes

  1. AHI Score

    Time frame: Next Day (next night)

    Comparisons of before and after AHI score by portable sleep testing device

  2. Questionnaire Improvement

    Time frame: night after, per quarter after for 1 year

    Comparisons of before and after PSQ (pediatric sleep questionnaire) scores

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Lagravere, DDS, PhD

CONTACT

[email protected]

(780) 492-7696

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Jul 15, 2022
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.