Photobiomodulation for Pediatric Hypertrophic Tonsils

University of Alberta

Status: Enrolling

Conditions: Tonsils Hypertrophy; Obstructive Sleep Apnea; Pediatric Sleep Apnea

Treatments: Device: PBM Tonsil Arm; Device: Sham PBM Tonsil Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05459935

00103330

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

PBM Tonsil Arm

Experimental group

Description:

Photobiomodulation exposure of hypertrophic tonsils

Treatment:

Device: PBM Tonsil Arm

Tonsil Control Arm

Sham Comparator group

Description:

Sham (non-powered) exposure of hypertrophic tonsils

Treatment:

Device: Sham PBM Tonsil Arm