Photobiomodulation for Pediatric Hypertrophic Tonsils
Primary Purpose
Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PBM Tonsil Arm
Sham PBM Tonsil Arm
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Sleep Apnea
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
Sites / Locations
- Enjoy DentalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
PBM Tonsil Arm
Tonsil Control Arm
Arm Description
Photobiomodulation exposure of hypertrophic tonsils
Sham (non-powered) exposure of hypertrophic tonsils
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
AHI Score
Comparisons of before and after AHI score by portable sleep testing device
Questionnaire Improvement
Comparisons of before and after PSQ (pediatric sleep questionnaire) scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05459935
Brief Title
Photobiomodulation for Pediatric Hypertrophic Tonsils
Official Title
Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sham intervention (nonactivated/unpowered phototherapy intervention)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PBM Tonsil Arm
Arm Type
Experimental
Arm Description
Photobiomodulation exposure of hypertrophic tonsils
Arm Title
Tonsil Control Arm
Arm Type
Sham Comparator
Arm Description
Sham (non-powered) exposure of hypertrophic tonsils
Intervention Type
Device
Intervention Name(s)
PBM Tonsil Arm
Other Intervention Name(s)
Fotona Lightwalker AT S
Intervention Description
exposure of hypertrophic tonsils to photobiomodulation
Intervention Type
Device
Intervention Name(s)
Sham PBM Tonsil Arm
Other Intervention Name(s)
Fotona Lightwalker AT S - non-powered
Intervention Description
non-powered exposure of hypertrophic tonsils to photobiomodulation
Primary Outcome Measure Information:
Title
Tonsil Size
Description
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.
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
AHI Score
Description
Comparisons of before and after AHI score by portable sleep testing device
Time Frame
Next Day (next night)
Title
Questionnaire Improvement
Description
Comparisons of before and after PSQ (pediatric sleep questionnaire) scores
Time Frame
night after, per quarter after for 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Lagravere, DDS, PhD
Phone
(780) 492-7696
Email
manuel@ualberta.ca
Facility Information:
Facility Name
Enjoy Dental
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5X 3N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enoch Ng, DDS
Email
enoch@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Manuel Lagravere Vich, DDS
Email
mlagravere@ualberta.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Photobiomodulation for Pediatric Hypertrophic Tonsils
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