Laser Light Therapy for Pediatric Sleep Apnea

Overseen By Manuel Lagravere, DDS, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Cancer, Hypertrophic tonsils treatment, Surgery scheduled

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called photobiomodulation (PBM), which uses laser light therapy, to determine if it can help children with obstructive sleep apnea breathe better at night. PBM offers a non-invasive alternative to surgery, which carries risks and may not always be effective, by shrinking swollen tonsils that block airways during sleep. The trial will compare the effects of PBM on the tonsils with a placebo treatment to assess its true impact. Children with very large tonsils and sleep apnea symptoms might be suitable for this study, provided they are not receiving other treatments or have cancerous growths. As an unphased trial, this study provides a unique opportunity for children to access a potentially groundbreaking non-invasive treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently being treated for hypertrophic tonsils, you would not be eligible to participate.

What prior data suggests that this laser light therapy is safe for pediatric sleep apnea?

Research has shown that photobiomodulation (PBM), a type of laser light therapy, is generally safe. Studies have applied this treatment in various situations and found it well-tolerated. No known side effects have been reported for using PBM on sleep breathing problems, such as sleep apnea. Although this therapy is new for treating sleep apnea and large tonsils in children, its use in adults for similar issues has shown minimal risk. This suggests PBM could be a safe option for children, but more specific data on pediatric use is still needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for pediatric sleep apnea, which often involve surgical removal of the tonsils or continuous positive airway pressure (CPAP) therapy, photobiomodulation (PBM) therapy uses laser light to target and reduce the size of hypertrophic tonsils. This non-invasive approach aims to improve breathing during sleep without surgery or devices that can be cumbersome for children. Researchers are excited about PBM therapy because it offers a potentially safer, more comfortable, and less disruptive alternative to traditional methods, with the potential for fewer side effects and quicker recovery times.

What evidence suggests that photobiomodulation is effective for pediatric obstructive sleep apnea?

Research shows that photobiomodulation (PBM), a type of laser light therapy, may help shrink swollen tonsils in children. Studies have found that PBM can significantly reduce tonsil size, with improvements seen immediately, three months later, and even a year after treatment. This trial will compare the effects of PBM, administered to participants in the PBM Tonsil Arm, with a sham treatment in the Tonsil Control Arm. Dentists have also used this therapy to help adults with snoring, and it has shown promise for treating adult sleep apnea. Although specific research on children with obstructive sleep apnea is lacking, the success in reducing tonsil size suggests it might help children breathe better during sleep. Importantly, PBM has not been linked to any known side effects when used for sleep breathing problems. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient must assent, parent must consent, to all pre and post follow up including sleep testing

My parent and I agree to follow normal referral protocols whether we join the study or not.

The tonsils are very enlarged.

Exclusion Criteria

I am scheduled for surgery to remove enlarged tonsils.

I am currently receiving treatment for enlarged tonsils.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation exposure of hypertrophic tonsils

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in tonsil size and AHI scores

1 week

1 visit (in-person)

Long-term Follow-up

Participants complete questionnaires and are monitored for changes in PSQ scores

1 year

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• PBM Tonsil Arm
• Sham PBM Tonsil Arm

Trial Overview 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.

How Is the Trial Designed?

Group I: PBM Tonsil Arm Experimental Treatment 1 Intervention

Photobiomodulation exposure of hypertrophic tonsils

Group II: Tonsil Control Arm Placebo Group 1 Intervention

Sham (non-powered) exposure of hypertrophic tonsils

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Photobiomodulation (PBM) therapy may have potential benefits for cancer patients, as it has been shown to increase survival rates in clinical trials, despite concerns about its use over tumor sites.

While some animal studies suggest PBM therapy could be harmful, many studies indicate it can damage tumors, enhance other cancer treatments, and stimulate the immune system, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and Cancer: What Is the Truth? Hamblin, MR., Nelson, ST., Strahan, JR.[2019]

Tonsillotomy (TT) with CO2-laser is significantly less painful than traditional tonsillectomy (TE), with TT children becoming pain-free after an average of 5 days compared to 8 days for TE children.

Both procedures effectively resolved breathing obstructions in children, but TT resulted in quicker recovery, less need for analgesics, and better weight gain post-surgery, with similar long-term outcomes regarding snoring and obstruction after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonsillectomy or tonsillotomy?--A randomized study comparing postoperative pain and long-term effects. Hultcrantz, E., Linder, A., Markström, A.[2019]

Photobiomodulation (PBM) therapy is recommended for the prevention of oral mucositis (OM) in cancer patients undergoing specific treatments, such as hematopoietic stem cell transplantation and head and neck radiotherapy, based on a systematic review of the literature.

Currently, there is insufficient evidence to provide guidelines for the treatment of established OM or chemotherapy-related OM, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Zadik, Y., Arany, PR., Fregnani, ER., et al.[2021]

In a study involving 101 children with severe chemotherapy-induced oral mucositis, laser photobiomodulation (PBM) significantly reduced the severity of mucositis, with 93.7% of PBM patients achieving a grade of less than 3 on the WHO scale by day 7 compared to 72% in the sham group (P = 0.01).

PBM also led to a significant reduction in pain levels on day 7, with a numeric pain rating scale score of 1 in the PBM group compared to 2.5 in the sham group (P < 0.006), and while there was a trend towards reduced analgesic use in the PBM group, it was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. Gobbo, M., Verzegnassi, F., Ronfani, L., et al.[2019]

Photobiomodulation (PBM) therapy, applied in one or three sessions, significantly increased the population of osteoblasts, which are crucial for bone formation, in rats undergoing tooth movement.

Three sessions of PBM not only enhanced collagen fiber density and new bone formation but also improved orthodontic movement, suggesting that PBM could be a beneficial adjunct therapy in orthodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental tooth movement and photobiomodulation on bone remodeling in rats. Gonçalves, CF., Desiderá, AC., do Nascimento, GC., et al.[2018]

High-power laser photobiomodulation (PBM) therapy significantly reduced pain in 25 cancer patients with refractory oral mucositis, with 94% of treatment sessions resulting in immediate pain relief.

Patients experienced an average pain reduction of 72% for chemotherapy-induced mucositis and 60% for radiotherapy-induced mucositis, with effects lasting around 6 days, indicating PBM as a safe and effective non-drug option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. Finfter, O., Cohen, R., Hanut, A., et al.[2023]

In a study involving 60 adult rats with critical bone defects, photobiomodulation therapy (PBM) at a dose of 45 J/cm2 significantly enhanced bone neoformation after 60 days compared to other doses, indicating its efficacy in promoting bone repair.

The results suggest that PBM is a promising treatment for bone healing, with the optimal dose identified as 45 J/cm2, which led to the highest percentage of new bone formation without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Photobiomodulation Therapy in Different Doses on Bone Repair of Critical Size Defects in Rats: A Histomorphometric Study. De Marco, AC., Torquato, LC., Gonçalves, PR., et al.[2022]

In a clinical trial involving 22 children undergoing tonsillectomy, the use of photobiomodulation therapy (PBMT) did not show a significant difference in pain relief compared to standard pain management methods after 24 hours.

However, there were concerns regarding safety, as two patients in the PBMT group experienced post-surgical bleeding, indicating that PBMT might increase the risk of complications in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation for Lowering Pain after Tonsillectomy: Low Efficacy and a Possible Unexpected Adverse Effect. Celsi, F., Staffa, P., Lamba, M., et al.[2022]

Photo-biomodulation (PBM), or low-level laser therapy, is gaining popularity for its wound healing and anti-inflammatory effects, making it a promising adjunctive treatment in cosmetic and surgical procedures.

Its applications in medicine and cosmetics include treating various skin conditions and enhancing skin rejuvenation, indicating its versatility and potential benefits in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Photo-Biomodulation Therapy in Facial Rejuvenation and Facial Plastic Surgery. De Cordova, JA.[2022]

Photobiomodulation therapy (PBMT) significantly reduces pain and odynophagia in the first 24 hours after tonsillectomy compared to those who did not receive PBMT, indicating its potential efficacy in postoperative care.

Despite the promising results, the evidence is limited, with only two studies included in the analysis, suggesting a need for further research to fully understand the benefits of PBMT in tonsillectomy recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does photobiomodulation therapy improve the postoperative outcomes of tonsillectomy? A systematic review and meta-analysis. de Arruda, JAA., Sampaio, GC., de Sena, ACVP., et al.[2022]

A study comparing two tonsil surgery techniques in 41 children over six years found that both intracapsular partial tonsillectomy (tonsillotomy) and traditional tonsillectomy had similar long-term effects on snoring, apneas, and overall health, indicating both methods are effective.

Parents reported high satisfaction rates with the surgical outcomes, with no significant differences in complications or recurrent issues between the two techniques, suggesting that tonsillotomy with CO(2)-laser is a safe and reliable alternative to traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of intracapsular partial tonsillectomy (tonsillotomy) compared with full tonsillectomy. Hultcrantz, E., Linder, A., Markström, A.[2015]

Microdebrider intracapsular tonsillectomy (MT) significantly improves sleep apnea symptoms in children, as evidenced by a statistically significant reduction in the apnea-hypopnea index (AHI) and apnea index in a study of 26 pediatric patients.

MT is associated with favorable surgical outcomes and minimal morbidity, making it a promising surgical option for treating obstructive sleep apnea due to adenotonsillar hypertrophy in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of microdebrider intracapsular adenotonsillectomy as validated by polysomnography. Reilly, BK., Levin, J., Sheldon, S., et al.[2009]

Photobiomodulation therapy (PBM-T) significantly reduces the severity of oral mucositis (OM) in cancer patients, as shown in a study involving 56 participants who received treatment over 4 weeks.

Combining PBM-T with photodynamic therapy (PDT) not only enhances the effectiveness of the treatment but also accelerates the healing process, reducing the time for lesion resolution from 15 days to 11 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and photodynamic therapy for the treatment of oral mucositis in patients with cancer. Pires Marques, EC., Piccolo Lopes, F., Nascimento, IC., et al.[2020]

Citations

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Photobiomodulation for pediatric hypertrophic tonsils Immediate, 3-month post-intervention, and 1 year post-intervention clinical photos showed significant tonsil size reduction from the low level laser therapy ...

2. withpower.com withpower.com/trial/phase-sleep-apnea-syndromes-8-2022-fcc37

Laser Light Therapy for Pediatric Sleep Apnea This trial is testing a laser light therapy called photobiomodulation (PBM) to help children with obstructive sleep apnea and swollen tonsils. PBM aims to ...

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Photobiomodulation for pediatric hypertrophic tonsils Immediate, 3-month post-intervention, and 1 year post-intervention clinical photos showed significant tonsil size reduction from the low level laser therapy ...

4. pdfs.semanticscholar.org pdfs.semanticscholar.org/0403/804d08d20bb7cb216ff0d14b779901e23cd6.pdf

Photobiomodulation for pediatric hypertrophic tonsils Immediate, 3-month post- intervention, and 1 year post-intervention clinical photos showed significant tonsil size reduction from the low level laser therapy ...

5. clinicaltrial.be clinicaltrial.be/en/details/78757?per_page=100&only_recruiting=0&only_eligible=0

Photobiomodulation for Pediatric Hypertrophic Tonsils - C... Photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05459935

Photobiomodulation for Pediatric Hypertrophic Tonsils The use of laser light therapy in ... Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7220119/

Photobiomodulation by low-level laser therapy in patients with ... The study's anxiety is to check whether the LLLT parameters of this protocol are sufficient to benefit sleep apnea patients. This protocol was ...