Photobiomodulation for Pediatric Hypertrophic Tonsils

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Alberta

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

visual indication of cancerous growth

currently under treatment (pharmacologic, other) for hypertrophic tonsils

already scheduled for surgical intervention of hypertrophic tonsils

Trial design

Design model

Parallel

Treatments tested in this trial

  • PBM Tonsil Arm

    Device

    exposure of hypertrophic tonsils to photobiomodulation

  • Sham PBM Tonsil Arm

    Device

    non-powered exposure of hypertrophic tonsils to photobiomodulation

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: PBM Tonsil ArmExperimental treatment 1 intervention
Group B: Tonsil Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
immediately after intervention

Secondary outcomes

1

AHI Score

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

Time frame
Next Day (next night)
2

Questionnaire Improvement

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

Time frame
night after, per quarter after for 1 year

Other outcomes

Sponsors and contacts

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