Photobiomodulation for Pediatric Hypertrophic Tonsils

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05459935
Study type	Interventional
Source	University of Alberta
Contact	Manuel Lagravere, DDS, PhD
Phone	(780) 492-7696
Email	manuel@ualberta.ca
Status	Recruiting
Phase	N/A
Start date	October 15, 2022
Completion date	January 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05857384` - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs	Phase 1
Recruiting	`NCT04547543` - Follow-up of Apneic Patients by Visio-consultation	N/A
Recruiting	`NCT05371509` - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study	N/A
Completed	`NCT02515357` - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea	N/A
Completed	`NCT05582070` - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction	N/A
Active, not recruiting	`NCT03189173` - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea	Phase 2
Completed	`NCT04084899` - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed	`NCT03032029` - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting	`NCT04028011` - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting	`NCT06047353` - Community Health Advocates for Motivating PAP Use in Our Neighborhoods.	N/A
Completed	`NCT05253963` - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea	N/A
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT06150352` - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed	`NCT03589417` - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting	`NCT04335994` - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing	N/A
Withdrawn	`NCT04063436` - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea	N/A
Recruiting	`NCT05385302` - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting	`NCT04572269` - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting	`NCT06467682` - 12-week Tele-exercise Program in Patients With OSA	N/A
Withdrawn	`NCT04011358` - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.