Transcranial Photobiomodulation for Obstructive Sleep Apnea

(STIL TIRED Trial)

Overseen By Courtney O'Brien

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Sedatives, Stimulants, Neuroleptics, others

Disqualifiers: Chronic insomnia, Circadian disorder, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

18 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot regularly use sedatives, stimulants, or certain other drugs more than two nights a week. If you use stimulants, you may need to stop before an MRI.

How does the treatment transcranial photobiomodulation (tPBM) for obstructive sleep apnea differ from other treatments?

Transcranial photobiomodulation (tPBM) is unique because it uses near-infrared or red light applied to the scalp to activate brain tissues, which is a non-invasive approach compared to traditional treatments for obstructive sleep apnea. This method aims to improve brain function and metabolism, which is different from other treatments that often focus on mechanical or surgical interventions to keep airways open. ^{1 2 3 4 5}

What is the purpose of this trial?

Obstructive sleep apnea (OSA) is a sleep disorder that is commonly treated using positive airway pressure, yet 50% of patients still experience residual sleepiness after successful therapy. A potential neuromodulation strategy that can decrease residual sleepiness is transcranial photobiomodulation (tPBM). tPBM is a neuromodulatory treatment that uses red and/or near infrared light to penetrate the cortex and can alter both cerebral metabolism and blood flow. However, this potential has never been explored before directly in sleep disordered individuals. This project aims to explore the effect of tPBM on sleepiness and understand the potential neural mechanism of tPBM in OSA. The short-term goal of this project is to collect pilot data, which is the first of its kind, and suggest tPBM as a potential modulator of sleepiness in OSA.

Research Team

Naomi Gaggi

Principal Investigator

NYU Langone Health

Ricardo Osario

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals with Obstructive Sleep Apnea (OSA) who still feel very sleepy during the day even after using standard treatments. Participants should be those looking to try a new therapy involving light to potentially improve wakefulness.

Inclusion Criteria

I have been treated for sleep apnea for over a year and my condition is under control.

Cognitively normal (Telephone Interview for Cognitive Status (TiCS) score ≥29)

I have been diagnosed with moderate to severe sleep apnea in the last year.

Exclusion Criteria

Other sleep-related breathing disorders based on American Academy of Sleep Medicine (AASM) criteria

Chronic regular use of stimulant if unable to complete a washout prior to MRI

I have been diagnosed with chronic insomnia or trouble falling asleep.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) treatment for approximately 12 minutes and complete assessments

1 day

1 visit (in-person)

Follow-up

Participants have the option to receive a second tPBM treatment and complete assessments 1 week post-initial visit

1 week

1 optional visit (in-person)

Treatment Details

Interventions

• Active tPBM

Trial Overview The study is testing transcranial photobiomodulation (tPBM), which uses specific types of light on the brain, as a treatment to reduce sleepiness in people with OSA. It's an early-stage trial aiming to gather initial data on tPBM's effectiveness and how it works.

Participant Groups

Group I: Participants with Moderate-to-Severe OSA Experimental Treatment 1 Intervention

Participants will receive tPBM treatment for approximately 12 minutes and complete assessments. Participants have the choice to participate in an optional follow-up 1 week post-initial visit, in which they will receive tPBM treatment for approximately 11-12 minutes and complete assessments at a different time of day.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

American Academy of Sleep Medicine Foundation

Collaborator

Trials

3

Recruited

100+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that effectively enhances higher electrophysiological oscillations in the brain, based on a review of 10 studies involving healthy individuals aged 18-80.

While tPBM shows promise in improving brain activity, the evidence regarding its effects on lower oscillatory frequencies remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. Shetty, SJ., Shetty, S., Shettigar, D., et al.[2023]

Transcranial photobiomodulation (tPBM) using a 1,064-nm laser significantly increases levels of oxygenated hemoglobin and oxidized cytochrome c oxidase in the brain, confirming previous findings over a 3-year study with 20 participants.

The study demonstrated that tPBM is effective in both young (average age 26.7) and older adults (average age 68.2), showing similar increases in brain metabolism and blood flow, indicating its potential as a safe and effective intervention across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation (tPBM) With 1,064-nm Laser to Improve Cerebral Metabolism of the Human Brain In Vivo. Pruitt, T., Wang, X., Wu, A., et al.[2022]

Transcranial photobiomodulation (tPBM) significantly enhances the metabolic and hemodynamic activities in the prefrontal cortex, with effects varying by wavelength (800 or 850 nm) and the specific site of application on the forehead, as demonstrated in a study involving 26 healthy young adults.

The study found that tPBM increased metabolic-hemodynamic coupling and altered the coherence of neurophysiological networks, indicating that tPBM can effectively modulate brain activity in a targeted manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site-specific effects of 800- and 850-nm forehead transcranial photobiomodulation on prefrontal bilateral connectivity and unilateral coupling in young adults. Shahdadian, S., Wang, X., Kang, S., et al.[2023]

In a study involving 20 individuals, those receiving near-infrared transcranial photobiomodulation (NIR t-PBM) showed a significant improvement in sexual function compared to those receiving sham therapy, indicating its potential efficacy for treating sexual dysfunction.

The improvements in sexual function were not linked to the antidepressant effects of t-PBM, suggesting that NIR t-PBM may have a distinct therapeutic action specifically for sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. Cassano, P., Dording, C., Thomas, G., et al.[2020]

Transcranial photobiomodulation (tPBM) showed promising effects in improving frontal lobe cognitive functions in three older adults with mild cognitive impairment (MCI) after 18 sessions over 9 weeks, with significant improvements in memory tests for all participants.

In addition to cognitive improvements, tPBM also led to reductions in anxiety and depressive symptoms, with one participant moving from severe to mild symptoms and others achieving normal levels, suggesting potential mental health benefits alongside cognitive enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. Cheung, MC., Lee, TL., Sze, SL., et al.[2023]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]

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

Transcranial Photobiomodulation (tPBM) With 1,064-nm Laser to Improve Cerebral Metabolism of the Human Brain In Vivo. [2022]

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

Site-specific effects of 800- and 850-nm forehead transcranial photobiomodulation on prefrontal bilateral connectivity and unilateral coupling in young adults. [2023]

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

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. [2023]