Phototherapy for Obstructive Sleep Apnea

Overseen By Enoch Ng

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Not diagnosed with OSA, using CPAP

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called phototherapy to assist individuals with obstructive sleep apnea (OSA), a condition that makes breathing difficult during sleep. The goal is to determine if phototherapy can stiffen parts of the throat to keep airways open, particularly for those who don't fully respond to dental devices designed to prevent airway collapse. Participants will be divided into groups, with some receiving phototherapy and others not, to compare results. Ideal candidates are those diagnosed with OSA who continue to experience symptoms despite using a dental appliance. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of new therapies.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be using CPAP (a breathing device for sleep apnea).

What prior data suggests that phototherapy is safe for treating obstructive sleep apnea?

Research has shown that phototherapy, a type of cold laser treatment, is being studied to help people with obstructive sleep apnea (OSA). This treatment works by firming the soft palate and parts of the tongue, preventing them from collapsing and blocking the airway, a common cause of OSA. A recent small study suggested that phototherapy alone might be effective for individuals with mild to severe OSA. Importantly, this study found no major safety issues or reasons to avoid using phototherapy, even when combined with other treatments like dental devices. Since phototherapy is now in a Phase 2 trial, earlier studies did not find serious safety problems, allowing it to progress. This suggests it is reasonably safe, but further research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about phototherapy for obstructive sleep apnea (OSA) because it offers a non-invasive alternative to current treatments like CPAP machines, oral appliances, and surgery. Unlike these standard options, phototherapy utilizes light to potentially target the root causes of OSA, such as inflammation or muscle tone in the throat, without the need for mechanical intervention. This innovative approach could provide a more comfortable and convenient solution for patients, potentially improving adherence and overall outcomes.

What evidence suggests that phototherapy might be an effective treatment for obstructive sleep apnea?

Research has shown that light therapy, or phototherapy, could be a promising treatment for obstructive sleep apnea (OSA). A recent small study found that phototherapy might benefit individuals with mild, moderate, or severe OSA. This trial will evaluate phototherapy in different experimental arms, labeled NL C3 and QN, to determine its effectiveness. The treatment uses a laser to firm up parts of the soft palate and tongue, helping to prevent them from collapsing during sleep—a common cause of OSA symptoms. Phototherapy has already reduced snoring, suggesting it might also help with sleep apnea. No known issues arise when using phototherapy alongside dental devices, making it a potential option for those who don't fully benefit from these devices alone. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with Obstructive Sleep Apnea who haven't fully benefited from using a dental appliance to keep their airways open during sleep. It's not specified who can't join, but typically those with contraindications to the treatment or severe health issues might be excluded.

Inclusion Criteria

I have not finished my oral appliance therapy.

I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

Using CPAP

I have not been diagnosed with sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive phototherapy in conjunction with oral appliance therapy to improve response in obstructive sleep apnea treatment

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Phototherapy

Trial Overview

The study is testing phototherapy, which uses cold laser therapy to stiffen the soft palate and tongue, potentially preventing collapse that causes OSA. The goal is to see if it improves outcomes for patients not fully helped by oral appliances.

How Is the Trial Designed?

Group I: QN Experimental Treatment 1 Intervention

Group II: NL C3 Experimental Treatment 1 Intervention

Group III: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A 17-year-old male with non-24 hour sleep-wake syndrome showed immediate improvement in his sleep-wake and body temperature rhythms after receiving phototherapy during hospitalization.

Polysomnography results indicated that phototherapy reduced total sleep time and stages 1 and 2 of sleep while increasing deeper sleep stages (3+4), suggesting that phototherapy can effectively normalize sleep patterns in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case of a non-24 h sleep-wake syndrome patient improved by phototherapy. Watanabe, T., Kajimura, N., Kato, M., et al.[2004]

Light therapy is being used more frequently to treat various sleep and psychiatric conditions, such as circadian rhythm sleep disorders and seasonal affective disorder, highlighting its growing importance in clinical practice.

Understanding the neural mechanisms behind circadian rhythms is essential for leveraging light therapy effectively, as it can significantly influence brain function and improve mood and sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illuminating rationale and uses for light therapy. Shirani, A., St Louis, EK.[2021]

Light therapy is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

Phototherapy is an effective treatment for various circadian sleep-wake disorders, including advanced and delayed sleep-wake phase disorders, non-24-hour sleep-wake rhythm disorder, jet lag, and night-shift work sleep-wake disorders.

The success of phototherapy relies on specific light characteristics such as intensity, duration, timing, and wavelength, but it should be avoided in patients with retinal disorders, necessitating consultation with an ophthalmologist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating circadian sleep-wake disorders by light]. Leger, D., Duforez, F., Gronfier, C.[2019]

Bright light therapy is an established and effective treatment for seasonal affective disorder and has shown therapeutic benefits for various neurological and psychiatric disorders, including sleep disorders and dementia.

Recent clinical trials have reinforced the efficacy of bright light therapy, highlighting its importance in mental health treatment and prompting advancements in light engineering for improved therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The current state of research in bright light therapy]. Bassa, D., Canazei, M., Hinterhuber, H., et al.[2021]

Citations

1.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.10840

Bright light therapy for CPAP-resistant OSA symptoms

This is the first study of bright light therapy for sleep and daytime symptoms of sleep apnea that do not resolve with CPAP.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06960200

Phototherapy for Non-responders to Oral Appliance ...

This has been shown to help with both snoring and can also help with OSA, as soft palate and tongue collapse are common areas for where OSA ...

3.

pmc.ncbi.nlm.nih.gov

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

Photobiomodulation by low-level laser therapy in patients with ...

Recently, a new and preliminary Erbium YAG laser treatment has been shown to be effective in the reduction of snoring and it has achieved a ...

4.

withpower.com

withpower.com/trial/phase-2-apnea-2024-096d2

Phototherapy for Obstructive Sleep Apnea

A recent pilot study has shown that phototherapy on its own may be able to treat selected patients with mild, moderate, or severe OSA. To our knowledge, there ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0278239124006827

Comparing Treatment Effectiveness and Patient-Reported ...

Comparing Treatment Effectiveness and Patient-Reported Outcome Measures of Four Treatment Options for Obstructive Sleep Apnea. Author links open overlay ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10835783/

Bright light therapy for CPAP-resistant OSA symptoms - PMC

Morning bright light was associated with consolidated sleep–wake cycles and reduced daytime sleepiness and depressive symptoms in patients with OSA who did not ...

7.

journals.lww.com

journals.lww.com/md-journal/fulltext/2020/03200/photobiomodulation_by_low_level_laser_therapy_in.39.aspx

Photobiomodulation by low-level laser therapy in patients...

Expected Results: In the individuals with OSA, photobiomodulation through LLLT will decrease the AHI. Additionally, when LLLT is applied in the oral cavity, a ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10566235/

Comparative outcomes in obstructive sleep apnea therapy

The results of this large retrospective study suggest an at least comparable effectiveness of CPAP and multilevel surgery for OSA [16]. With 69 ...