Phototherapy for Obstructive Sleep Apnea

Overseen By Enoch Ng

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alberta

Disqualifiers: Not using CPAP

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how light therapy, known as phototherapy or photobiomodulation (PBM), can assist individuals with obstructive sleep apnea (OSA). PBM uses lasers or LEDs to interact with the body and may improve sleep quality and reduce snoring by stabilizing the airway. Researchers aim to determine if PBM can also enhance the comfort and effectiveness of using a CPAP machine. The trial seeks participants who currently use CPAP but have difficulty tolerating it or continue to experience snoring. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on participants who are using CPAP for sleep apnea.

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

Previous studies have shown that light therapy, including photobiomodulation (PBM), is well-tolerated by people. Research suggests that PBM can improve sleep quality and reduce snoring in adults by stabilizing the upper airway, which is crucial for treating obstructive sleep apnea (OSA).

Administered by trained professionals, PBM is generally safe. It has been used successfully in areas like wound healing and dental care, yielding positive results with few side effects. Notably, PBM has fewer side effects compared to treatments like dental devices for sleep.

Bright light therapy, another form of light therapy, has been found to be a safe and cost-effective way to improve sleep in people with sleep apnea. This indicates that light therapy, in general, is a promising and safe treatment option for sleep-related issues, including OSA. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Phototherapy is unique for treating obstructive sleep apnea because it doesn't rely on mechanical devices or surgical interventions, which are common in current treatments like CPAP machines and surgeries. Instead, phototherapy uses light to stimulate biological processes that can improve airway function and reduce symptoms. Researchers are excited about this approach because it might offer a non-invasive, comfortable alternative that could enhance patient compliance and overall effectiveness without the discomfort or inconvenience associated with traditional treatments.

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

Research has shown that photobiomodulation (PBM), a type of light therapy using lasers or LEDs, may improve sleep quality and reduce snoring in adults. Recent studies suggest that PBM can stabilize the upper airway, potentially treating obstructive sleep apnea (OSA) like dental sleep devices but with fewer side effects. One small study found that light therapy alone could be effective for individuals with mild to severe OSA. Additionally, PBM has proven helpful in other medical areas, such as wound healing and pain management, indicating its wide-ranging potential. While PBM appears promising, more research is needed to fully understand its effectiveness for OSA. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Obstructive Sleep Apnea who may benefit from a light therapy called Photobiomodulation (PBM) to improve their use of CPAP machines. Specific eligibility criteria are not provided, but typically participants would need to have a confirmed diagnosis of OSA and be current or potential users of CPAP.

Inclusion Criteria

Using CPAP

I struggle with using CPAP or have issues with snoring.

Exclusion Criteria

I do not use a CPAP machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation therapy in combination with CPAP to assess its impact on CPAP compliance

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phototherapy

Trial Overview The study is testing if PBM can help stabilize the upper airway in people with Obstructive Sleep Apnea, potentially reducing the need for high pressures in CPAP devices and improving patient compliance. The effectiveness of combining PBM with CPAP treatment has not been previously explored.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. 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 ...

2. 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 ...

3. 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05917119

Study Details | NCT05917119 | Bright Light Therapy for OSA The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week ...