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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up night after, per quarter after for 1 year
Awards & highlights

Study Summary

This trialwill look at whether laser light therapy can help children with difficulty breathing while sleeping, potentially avoiding the risks of 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tonsil Size
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,070 Total Patients Enrolled

Media Library

PBM Tonsil Arm (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05459935 — N/A
Pediatric Sleep Apnea Research Study Groups: PBM Tonsil Arm, Tonsil Control Arm
Pediatric Sleep Apnea Clinical Trial 2023: PBM Tonsil Arm Highlights & Side Effects. Trial Name: NCT05459935 — N/A
PBM Tonsil Arm (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459935 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the requirements for this medical study limited to persons aged 35 and below?

"To be considered for recruitment in this trial, potential patients must fall within the 6-12 age range. There are 54 studies that accept applicants below 18 years of age and 300 for those over 65."

Answered by AI

Are there any open slots for enrollment in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this trial is actively recruiting patients who meet the criteria. The study was initially posted on October 15th 2022 and was recently revised on October 28th 2022; 64 individuals are being sought out at 1 location."

Answered by AI

Who is eligible to join this research endeavor?

"This research project is recruiting 64 children between the ages of 6 and 12 who have hypertrophied tonsils. To be eligible, participants must provide Brodsky visual grading scores for their tonsils (3/4), as well as assent to parental consent for pre- and post-treatment sleep testing. Furthermore, both patient and parent must agree to regular referral protocols even if they don't join the study."

Answered by AI

How many subjects are enrolled in this experiment?

"Affirmative. As per the information found on clinicaltrials.gov, this research is presently looking to enroll participants--the trial was first announced on October 15th 2022 and last updated on October 28th 2022. 64 people need to be recruited from a single medical facility for the study's completion."

Answered by AI
~20 spots leftby Jan 2025