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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called transcranial photobiomodulation (tPBM) to reduce sleepiness in people with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. tPBM uses special red or near-infrared light to potentially improve brain activity and blood flow, aiming to ease sleepiness that persists despite current OSA treatments. The trial seeks participants with moderate to severe OSA who are already using CPAP successfully (a machine that helps keep airways open) but still feel sleepy during the day. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options for OSA-related sleepiness.

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.

What prior data suggests that transcranial photobiomodulation is safe for obstructive sleep apnea?

Research shows that transcranial photobiomodulation (tPBM) is generally safe and well-tolerated. This non-invasive treatment uses red or near-infrared light to influence brain activity. Studies have found that it can improve brain function and blood flow, potentially aiding conditions like obstructive sleep apnea (OSA).

Importantly, no major safety concerns have been reported for tPBM. Various studies have used it without significant side effects, making it a promising option for reducing symptoms like ongoing sleepiness in OSA. For those considering participation in a clinical trial, the safety of tPBM is reassuring based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial photobiomodulation (tPBM) for obstructive sleep apnea (OSA) because it offers a non-invasive and drug-free treatment option. Unlike traditional therapies like CPAP machines, which require wearing a mask during sleep, tPBM uses light therapy applied to the head to potentially improve sleep quality. This approach targets brain activity linked to sleep regulation, offering a new mechanism of action that could benefit those who struggle with or tolerate current OSA treatments poorly.

What evidence suggests that transcranial photobiomodulation is effective for obstructive sleep apnea?

This trial will investigate the effects of transcranial photobiomodulation (tPBM) on individuals with obstructive sleep apnea (OSA). Studies have shown that tPBM can improve sleep quality and reduce feelings of sleepiness. Earlier research found that tPBM boosts brain activity in both young and older adults. Another study discovered that tPBM significantly lessens feelings of sleepiness, anxiety, stress, and depression after treatment. This treatment uses red and near-infrared light to alter brain function and improve blood flow, which might help reduce sleepiness in people with OSA. Although tPBM hasn't been directly tested on OSA yet, its positive effects on sleep and mood are encouraging. ^{1 3 4 6 7}

Who Is on the Research Team?

Ricardo Osario

Principal Investigator

NYU Langone Health

Naomi Gaggi

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350269/

Enhancing sleep, wakefulness, and cognition with transcranial ... To date, 17 studies have been conducted that explored sleep quality as an outcome measure after t-PBM, including individuals with traumatic ...

2. withpower.com withpower.com/trial/transcranial-photobiomodulation-for-obstructive-sleep-apnea-b7472

Transcranial Photobiomodulation for Obstructive Sleep ... 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 ...

3. mdpi.com mdpi.com/2304-6732/11/7/670

TransPhoM-DS Study Grant Report: Rationale and ... t-PBM has been shown to improve cognitive functions such as language, attention, inhibition, learning, and memory, including working memory.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10840571/

Transcranial photobiomodulation for brain diseases: review of ... The clinical results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1) showed that tPBM (808 nm) within 24 h after stroke is safe ...

5. researchgate.net researchgate.net/publication/389952261_Advanced_Intervention_Effects_of_Pulsed_and_Steady_Transcranial_Photobiomodulation_on_Sleep_Mood_and_EEG_Signal_Regulation

(PDF) Advanced Intervention Effects of Pulsed and Steady ... Results Paired t ‐tests showed PW tPBM significantly improved sleepiness, anxiety, stress, and depression scores post‐intervention ( p < 0.05).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06698809

Study Details | NCT06698809 | Obstructive Sleep Apnea ... 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.

7. mdpi.com mdpi.com/2304-6732/9/8/507

Tolerability and Safety of Transcranial Photobiomodulation ... Aim: To further investigate the t-PBM safety profile, this study aims to evaluate the tolerability and safety of t-PBM for the treatment of ...