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

Trial Summary

What is the purpose of this trial?

Obstructive sleep apnea (OSA) is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. However, while the majority of OSA patients are able to tolerate the use of oral appliance therapy (OAT) for OSA, some patients are incomplete responders to OAT. These patients, despite having improvement, may still have a disease index above the diagnostic threshold for OSA. Phototherapy (laser therapy) has been used as a method to stiffen the soft palate and parts of the tongue to prevent their collapse. This is a type of cold laser therapy that does not cut/ablate tissue (similar to healing laser therapies). 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 occurs inside the airway. 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 are no contraindications to combining phototherapy and dental sleep appliance therapy.

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 data supports the effectiveness of the treatment Phototherapy for Obstructive Sleep Apnea?

Phototherapy has been shown to be effective in treating various sleep disorders by influencing circadian rhythms, which are the body's internal clock that regulates sleep-wake cycles. It is used for conditions like circadian rhythm sleep disorders and seasonal affective disorder, suggesting it may help with sleep-related issues. ^{1 2 3 4 5}

How does phototherapy differ from other treatments for obstructive sleep apnea?

Phototherapy is unique because it uses light exposure to influence sleep patterns, which is different from other treatments like CPAP machines that physically keep airways open. It works by adjusting the body's internal clock, making it potentially useful for sleep disorders related to circadian rhythms. ^{1 2 3 6 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treating circadian sleep-wake disorders by light]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Phototherapy with ultraviolet radiation: a study of hormone parameters and psychological effects. [2018]

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

Illuminating rationale and uses for light therapy. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Phototherapy device effectiveness in Nigeria: irradiance assessment and potential for improvement. [2013]

6. Australia pubmed.ncbi.nlm.nih.gov

Case of a non-24 h sleep-wake syndrome patient improved by phototherapy. [2004]

7. Germany pubmed.ncbi.nlm.nih.gov

[The current state of research in bright light therapy]. [2021]