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

Trial Summary

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 data supports the effectiveness of the treatment Laser Light Therapy for Pediatric Sleep Apnea?

Research suggests that photobiomodulation therapy (PBMT) may help reduce pain and the need for painkillers after tonsil surgery, which is often performed to treat sleep apnea in children. However, its direct impact on sleep apnea symptoms is not well-defined, and more studies are needed to confirm its effectiveness for this specific condition. ^{1 2 3 4 5}

Is laser light therapy safe for use in humans?

Research on laser light therapy, also known as photobiomodulation (PBM), shows it is generally safe for humans, as it has been used in studies for conditions like oral mucositis in children and bone repair in rats without significant side effects. ^{6 7 8 9 10}

How is the treatment for pediatric sleep apnea using laser light therapy different from other treatments?

Laser light therapy, or photobiomodulation (PBM), is unique because it uses light to stimulate healing and reduce inflammation, unlike traditional treatments that might involve surgery or mechanical devices. This non-invasive approach is being explored for its potential to improve conditions like sleep apnea by targeting tissues with light to promote better function. ^{6 7 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 (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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation for Lowering Pain after Tonsillectomy: Low Efficacy and a Possible Unexpected Adverse Effect. [2022]

2. Iran pubmed.ncbi.nlm.nih.gov

Does photobiomodulation therapy improve the postoperative outcomes of tonsillectomy? A systematic review and meta-analysis. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Long-term effects of intracapsular partial tonsillectomy (tonsillotomy) compared with full tonsillectomy. [2015]

4. Ireland pubmed.ncbi.nlm.nih.gov

Tonsillectomy or tonsillotomy?--A randomized study comparing postoperative pain and long-term effects. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of microdebrider intracapsular adenotonsillectomy as validated by polysomnography. [2009]

6. United States 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. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Experimental tooth movement and photobiomodulation on bone remodeling in rats. [2018]

9. Iran 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. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Photobiomodulation and photodynamic therapy for the treatment of oral mucositis in patients with cancer. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation and Cancer: What Is the Truth? [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. [2021]