Photobiomodulation for Pediatric Hypertrophic Tonsils

Study Overview
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Brief Summary
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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.

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

Conditions
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Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy

Intervention / Treatment
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* Device: PBM Tonsil Arm
* Device: Sham PBM Tonsil Arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |