Clinical trial NCT05459935: Photobiomodulation for Pediatric Hypertrophic Tonsils
Official title: Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Sleep Apnea
Obstructive Sleep Apnea
Tonsils Hypertrophy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tonsil Size
timeFrame: immediately after intervention
Secondary outcomes:
measure: AHI Score
timeFrame: Next Day (next night)
measure: Questionnaire Improvement
timeFrame: night after, per quarter after for 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Enjoy Dental
state: Alberta
Study officials:
References: