Photobiomodulation for Pediatric Hypertrophic Tonsils
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PBM Tonsil Arm, Sham PBM Tonsil Arm.
- Who it may be relevant to
- Registry conditions: Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
Overview
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.
Interventions
- Device PBM Tonsil Arm
exposure of hypertrophic tonsils to photobiomodulation - Device Sham PBM Tonsil Arm
non-powered exposure of hypertrophic tonsils to photobiomodulation
Primary outcome measures
- Tonsil Size [Time frame: immediately after intervention]
Secondary outcome measures (2)
- AHI Score [Time frame: Next Day (next night)]
- Questionnaire Improvement [Time frame: night after, per quarter after for 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Enjoy Dental — Edmonton
Identifiers
NCT: NCT05459935 · 00103330