What side effects are associated with this type of intervention?

Common treatments for Pediatric Sleep Apnea, such as adenotonsillectomy, carry risks of complications like secondary hemorrhage, respiratory issues, and increased susceptibility to infections. Non-surgical treatments like anti-inflammatory agents and myofunctional therapy generally have fewer side effects, though specific data are limited. Photobiomodulation (PBM), a non-invasive therapy, has no known side effects reported for treating sleep breathing disorders.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for pediatric sleep apnea that utilize photobiomodulation (PBM) or similar non-cutting laser light therapies aimed at reducing hypertrophic tonsils. The primary treatment for pediatric obstructive sleep apnea typically involves surgical removal of the tonsils and adenoids (adenotonsillectomy). Other non-surgical treatments, such as continuous positive airway pressure (CPAP) therapy, are also used but do not involve laser light therapy. Research is ongoing to explore the efficacy and safety of PBM for this condition.

What other types of research exist?

Promising novel alternatives to PBM for pediatric sleep apnea include transcutaneous trigeminal nerve stimulation (TTNS), which has shown potential in managing ADHD symptoms and may have applications in sleep apnea, and complementary and alternative medicine (CAM) approaches such as biofeedback and relaxation-response training. Additionally, adenotonsillectomy remains a standard treatment, though careful observation and watchful waiting may be warranted in some cases.

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Photobiomodulation

Laser Light Therapy for Pediatric Sleep Apnea

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Already scheduled for surgical intervention of hypertrophic tonsils

Currently under treatment (pharmacologic, other) for hypertrophic tonsils

Timeline

Screening 3 weeks

Treatment Varies

Follow Up night after, per quarter after for 1 year

Summary

This trial is testing a laser light therapy called photobiomodulation (PBM) to help children with obstructive sleep apnea and swollen tonsils. PBM aims to reduce swelling and improve breathing without the need for surgery.

Who is the study for?

This trial is for children with obstructive sleep apnea due to swollen tonsils, graded as moderate to severe. They must agree to follow-up tests and adhere to normal referral protocols. Children already receiving treatment for swollen tonsils or scheduled for surgery, and those with signs of cancer are excluded.

What is being tested?

The study is testing photobiomodulation (PBM), a non-surgical laser light therapy, on children's enlarged tonsils. It aims to reduce swelling and improve breathing during sleep without the risks associated with surgery.

What are the potential side effects?

Currently, there are no known side effects from using PBM for treating sleep-related breathing disorders; however, this trial will further investigate its safety in children.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for surgery to remove enlarged tonsils.

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I am currently receiving treatment for enlarged tonsils.

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I can see a growth on my body that may be cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ night after, per quarter after for 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~night after, per quarter after for 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and night after, per quarter after for 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tonsil Size

Secondary study objectives

AHI Score

Questionnaire Improvement

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PBM Tonsil ArmExperimental Treatment1 Intervention

Photobiomodulation exposure of hypertrophic tonsils

Group II: Tonsil Control ArmPlacebo Group1 Intervention

Sham (non-powered) exposure of hypertrophic tonsils

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pediatric Sleep Apnea (PSA) include adenotonsillectomy, which involves the surgical removal of the tonsils and adenoids to clear the airway, and continuous positive airway pressure (CPAP) therapy, which uses a machine to keep the airway open during sleep. Photobiomodulation (PBM) is a non-invasive treatment that uses laser light to reduce the size of hypertrophic tonsils, potentially improving airway patency without surgery. This matters for PSA patients as it offers a less invasive option with fewer risks and complications compared to traditional surgical methods, potentially improving breathing and sleep quality in children.

Paediatrics: how to manage obstructive sleep apnoea syndrome.Treatment of Obstructive Sleep Apnea in Children: Handling the Unknown with Precision.Pediatric Obstructive Sleep Apnea: Where Do We Stand?