Photobiomodulation for Pediatric Hypertrophic Tonsils

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459935
• Other study ID #: 00103330
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: January 2030

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: Manuel Lagravere, DDS, PhD
• Phone: (780) 492-7696
• Email: manuel[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 2030
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypertrophy
• Obstructive Sleep Apnea
• Pediatric Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• PBM Tonsil Arm
exposure of hypertrophic tonsils to photobiomodulation
• Sham PBM Tonsil Arm
non-powered exposure of hypertrophic tonsils to photobiomodulation

Locations

Country	Name	City	State
Canada	Enjoy Dental	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AHI Score	Comparisons of before and after AHI score by portable sleep testing device	Next Day (next night)
Secondary	Questionnaire Improvement	Comparisons of before and after PSQ (pediatric sleep questionnaire) scores	night after, per quarter after for 1 year