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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM Tonsil Arm | Experimental | Photobiomodulation exposure of hypertrophic tonsils |
|
| Tonsil Control Arm | Sham Comparator | Sham (non-powered) exposure of hypertrophic tonsils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM Tonsil Arm | Device | exposure of hypertrophic tonsils to photobiomodulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AHI Score | Comparisons of before and after AHI score by portable sleep testing device | Next Day (next night) |
| Questionnaire Improvement | Comparisons of before and after PSQ (pediatric sleep questionnaire) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Lagravere, DDS, PhD | Contact | (780) 492-7696 | manuel@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enjoy Dental | Recruiting | Edmonton | Alberta | T5X 3N5 | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Sham intervention (nonactivated/unpowered phototherapy intervention)
| Sham PBM Tonsil Arm | Device | non-powered exposure of hypertrophic tonsils to photobiomodulation |
|
|
| night after, per quarter after for 1 year |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |