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Photobiomodulation for Pediatric Hypertrophic Tonsils

Sponsor
University of Alberta (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05459935
Collaborator
(none)
64
Enrollment
2
Arms
88
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PBM Tonsil Arm
  • Device: Sham PBM Tonsil Arm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Sham intervention (nonactivated/unpowered phototherapy intervention)
Primary Purpose:
Treatment
Official Title:
Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: PBM Tonsil Arm

Photobiomodulation exposure of hypertrophic tonsils

Device: PBM Tonsil Arm
exposure of hypertrophic tonsils to photobiomodulation
Other Names:
  • Fotona Lightwalker AT S

    		•
    Sham Comparator: Tonsil Control Arm

    Sham (non-powered) exposure of hypertrophic tonsils

    Device: Sham PBM Tonsil Arm
    non-powered exposure of hypertrophic tonsils to photobiomodulation
    Other Names:
  • Fotona Lightwalker AT S - non-powered

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tonsil Size [immediately after intervention]

      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

    1. AHI Score [Next Day (next night)]

      Comparisons of before and after AHI score by portable sleep testing device

    2. Questionnaire Improvement [night after, per quarter after for 1 year]

      Comparisons of before and after PSQ (pediatric sleep questionnaire) scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT05459935
    Other Study ID Numbers:
    • 00103330
    First Posted:
    Jul 15, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Hypertrophy

    Study Results

    No Results Posted as of Jul 15, 2022