Pediatric Sleep ApneaNCT05459935
Photobiomodulation for Pediatric Hypertrophic Tonsils
A study testing PBM Tonsil Arm in people with Pediatric Sleep Apnea and Obstructive Sleep Apnea, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy
- What is being tested?
- PBM Tonsil Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2022to 6 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- visual indication of cancerous growth
- currently under treatment (pharmacologic, other) for hypertrophic tonsils
- already scheduled for surgical intervention of hypertrophic tonsils
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Enjoy Dental
Edmonton, Alberta, T5X 3N5
Enoch Ng, DDS, enoch@ualberta.ca
Manuel Lagravere Vich, DDS, mlagravere@ualberta.ca
About this study
Official title: Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
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
Read more
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.
- Being tested
- PBM Tonsil Arm, Sham PBM Tonsil Arm
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM Tonsil ArmDevice
Also called Fotona Lightwalker AT S
exposure of hypertrophic tonsils to photobiomodulation
Sham PBM Tonsil ArmDevice
Also called Fotona Lightwalker AT S - non-powered
non-powered exposure of hypertrophic tonsils to photobiomodulation
| Study group | Role | What they receive |
|---|---|---|
| PBM Tonsil Arm | Experimental | Photobiomodulation exposure of hypertrophic tonsils Receives: Device: PBM Tonsil Arm |
| Tonsil Control Arm | Sham comparator | Sham (non-powered) exposure of hypertrophic tonsils Receives: Device: Sham PBM Tonsil Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after intervention
Secondary outcomes (2)
AHI Score
Comparisons of before and after AHI score by portable sleep testing device
Measured: Next Day (next night)
Questionnaire Improvement
Comparisons of before and after PSQ (pediatric sleep questionnaire) scores
Measured: night after, per quarter after for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Oct 2022
- Primary completion6 Jul 2030 (estimated)
- Study completion6 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459935
- Sponsor's protocol ID
- 00103330
- Status last verified
- Sep 2026
- First submitted
- 19 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
- ClinicalTrials.gov ID
- NCT05459935
- Acronym / sponsor ID
- 00103330
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 6 Jul 2030 (estimated)
- Study completion
- 6 Dec 2030 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM Tonsil Arm | Experimental | Device: PBM Tonsil ArmPhotobiomodulation exposure of hypertrophic tonsils |
| Tonsil Control Arm | Sham comparator | Device: Sham PBM Tonsil ArmSham (non-powered) exposure of hypertrophic tonsils |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- visual indication of cancerous growth
- currently under treatment (pharmacologic, other) for hypertrophic tonsils
- already scheduled for surgical intervention of hypertrophic tonsils
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBM Tonsil ArmAlso: Fotona Lightwalker AT Sexposure of hypertrophic tonsils to photobiomodulation | Device | PBM Tonsil Arm |
| Sham PBM Tonsil ArmAlso: Fotona Lightwalker AT S - non-powerednon-powered exposure of hypertrophic tonsils to photobiomodulation | Device | Tonsil Control Arm |
Primary outcome
Tonsil Size
Time frame: immediately after intervention
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.
2 secondary outcomes
AHI Score
Time frame: Next Day (next night)
Questionnaire Improvement
Time frame: night after, per quarter after for 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM Tonsil Arm in people with Pediatric Sleep Apnea and Obstructive Sleep Apnea, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Lagravere, DDS, PhD ((780) 492-7696, manuel@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tonsil Size (time frame: immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.