Bright Light Therapy for Sleep Apnea

(BrightDaysII Trial)

Overseen By L. A Pisarov

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Hypnotics, Photosensitivity drugs

Disqualifiers: Shift work, Narcolepsy, CHF, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Bright Light Therapy (BLT) might benefit individuals with obstructive sleep apnea (OSA) who experience daytime sleepiness despite using CPAP machines. BLT is a non-drug treatment that uses light to regulate sleep patterns and enhance alertness. Participants will experience both real and placebo BLT to determine any differences. It suits those who consistently use CPAP but still feel tired during the day. As an unphased trial, this study provides a unique opportunity to explore a non-drug treatment that could boost daily alertness and improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on alertness-promoting medication, you must be on a stable dose for at least one month before the study and not change the dose during the study.

What prior data suggests that Bright Light Therapy is safe for treating residual daytime symptoms of sleep apnea?

Studies have shown that Bright Light Therapy (BLT) is generally safe and easy to manage. Research indicates that it can significantly improve sleep and reduce symptoms with minimal side effects. Specifically, one study found that BLT is a safe and affordable method to help people with sleep apnea sleep better. Another study highlighted that exposure to bright light can enhance sleep and mood in various conditions, including sleep apnea. Overall, BLT is considered a safe option for treating sleep-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Bright Light Therapy (BLT) for sleep apnea because it offers a non-invasive and drug-free approach to managing the condition. Unlike standard treatments like CPAP machines, which can be cumbersome and uncomfortable, BLT uses bright light delivered via glasses, making it a more convenient option. This innovative method aims to regulate the body's internal clock, potentially improving sleep quality and reducing apnea events without the need for masks or medications.

What evidence suggests that Bright Light Therapy is effective for treating residual daytime symptoms of sleep apnea?

Research has shown that Bright Light Therapy (BLT) can improve sleep quality and increase daytime alertness. It reduces the time spent awake after initially falling asleep and enhances overall sleep quality. In this trial, participants will receive either BLT via glasses or a sham BLT as a comparator. For individuals with obstructive sleep apnea who do not respond well to CPAP treatment, BLT has helped establish more regular sleep patterns. Studies also indicate that BLT can increase total sleep time and improve mood by adjusting the body's internal clock. These findings suggest that BLT might effectively reduce daytime sleepiness for sleep apnea patients using CPAP. ^{1 2 6 7 8}

Who Is on the Research Team?

Isabella Soreca, MD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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 despite using CPAP machines regularly. They must have used their CPAP for at least 3 months, not have central sleep apnea or certain other health conditions, and cannot be on medications that affect light sensitivity.

Inclusion Criteria

I haven't used BLT for at least one month.

You have been using CPAP or BiPAP for at least 3 months, wearing it for more than 6 hours a night on most nights, and your sleep apnea is well controlled with an AHI of 10 or less when using the device.

I often feel very sleepy during the day.

Exclusion Criteria

I have central sleep apnea and need oxygen therapy through my nose.

I do not have worsening heart failure that requires hospitalization.

You are currently addicted to drugs or alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bright Light Therapy and Sham Bright Light Therapy in a crossover design, each for 4 weeks

8 weeks

Visits at baseline, week 4, week 8, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bright Light Therapy (BLT)

Trial Overview

The study tests Bright Light Therapy (BLT) to see if it helps reduce daytime sleepiness in OSA patients who use CPAP. Participants will try both real BLT and a fake version without knowing which is which, each for four weeks, to compare effects.

How Is the Trial Designed?

Group I: BLT Experimental Treatment 1 Intervention

Bright light therapy delivered via glasses

Group II: s-BLT Placebo Group 1 Intervention

Sham Bright light therapy

Bright Light Therapy (BLT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Circadian rhythm sleep disorders
• Insomnia

Approved in European Union as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Circadian rhythm sleep disorders
• Insomnia

Approved in Canada as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Circadian rhythm sleep disorders
• Insomnia

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Bright light therapy (BLT) is feasible and well-tolerated in an acute psychiatric inpatient setting, with a high adherence rate of 94% and minimal side effects.

Patients receiving BLT showed significant reductions in depressive symptoms and improvements in functioning, with five sessions appearing to be the optimal amount for treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Adjunctive Bright Light Therapy for Depressive Symptoms on an Acute Psychiatric Floor. Trinh, A., Jain, P., Sabahath, S., et al.[2023]

In a study of patients with moderate to severe obstructive sleep apnea (OSA) who failed at least 6 months of CPAP therapy, 85.7% experienced significant improvement in their condition after undergoing surgical treatment, indicating that surgery can be a highly effective alternative for this group.

Surgical intervention led to substantial improvements in sleepiness (Epworth Sleepiness Scale), quality of life (Sleep Apnea Quality of Life Index), and normalized blood pressure, suggesting that surgery may be a better management option than CPAP for certain patients who struggle with adherence to CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining the timing of surgery for obstructive sleep apnea in anatomically favorable patients. Rotenberg, BW., Theriault, J., Gottesman, S.[2022]

Bright light therapy is effective for treating seasonal affective disorder and may also benefit various circadian rhythm sleep disorders, such as delayed and advanced sleep phase syndromes, based on a review of existing literature.

This therapy is relatively safe and its success relies on timing, suggesting that personalized approaches to treatment could enhance its effectiveness in managing sleep-wake rhythm misalignments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. Poirrier, R.[2006]

Bright light therapy (BLT) showed significant antidepressant effects in three pregnant women, with a 33% improvement in depressive symptoms after 2 weeks and a 55% improvement after 4 weeks of treatment.

No side effects were reported during the BLT treatment, indicating it is a well-tolerated option for treating non-seasonal depression in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. Krzystanek, M., Krupka-Matuszczyk, I.[2006]

In a study of 201 patients with obstructive sleep apnea (OSA), 84% of those using continuous positive airway pressure (CPAP) reported improved daytime alertness after 12-24 months.

Patients with moderate OSA who underwent surgery experienced an 85% improvement in daytime alertness, while those with mild OSA improved by 64% and 66% through weight loss or changing sleep position, highlighting the effectiveness of various treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcome of sleep apnea. Watson, RK., Thompson, AS.[2007]

In a pilot study involving 30 renal transplant recipients, morning bright light therapy (BLT) for 3 weeks led to a significant improvement in sleep timing, with participants waking up 24 minutes earlier on average.

While BLT showed preliminary benefits in improving subjective feelings and depressive symptoms, these changes were not statistically significant, indicating the need for further research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial. Burkhalter, H., Wirz-Justice, A., Denhaerynck, K., et al.[2016]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

Obstructive Sleep Apnea Syndrome (OSAS) is a common and serious condition that can lead to significant health risks if left untreated, but it is easy to diagnose and has a high response rate to treatment.

The primary treatment for OSAS is Continuous Positive Airway Pressure (CPAP), which helps keep the airway open during sleep, improving sleep quality, oxygen levels, and daytime alertness; alternative treatments include bilevel positive airway pressure, surgery, and lifestyle changes like weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When to suspect obstructive sleep apnea syndrome. Symptoms may be subtle, but treatment is straightforward. Attarian, HP., Sabri, AN.[2019]

In a study involving 14 patients with sleep apnea, morning bright light therapy (BLT) was found to significantly reduce wake after sleep onset and improve circadian rhythm amplitude compared to sham treatment.

Patients reported decreased daytime sleepiness and depressive symptoms during the early stages of BLT, suggesting that this therapy could be a beneficial adjunct for those experiencing persistent symptoms despite CPAP treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy for CPAP-resistant OSA symptoms. Soreca, I., Arnold, N., Dombrovski, AY.[2023]

Bright light therapy (BLT) can be beneficial for some patients with Alzheimer's-type dementia, as it may help reduce delusions and agitation, but caution is necessary due to potential adverse effects.

In one case, an 80-year-old woman experienced increased agitation and developed delusional symptoms after 14 days of BLT, leading to the treatment's discontinuation, which resulted in the rapid resolution of her symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. Schindler, SD., Graf, A., Fischer, P., et al.[2022]

In a pilot study involving 48 outpatients with major depressive disorder, Bright Light Therapy (BLT) significantly improved depressive symptoms after 3 weeks of daily treatment, with effects lasting for at least 4 weeks.

The study found no significant differences in the efficacy of BLT between patients with melancholic versus atypical features of depression, suggesting that BLT may be a versatile treatment option for various mood disorder subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. Naus, T., Burger, A., Malkoc, A., et al.[2018]

A short-term daytime CPAP trial significantly improved sleep quality during the titration night, with higher total sleep time and sleep efficiency compared to usual care.

Patients who underwent daytime CPAP acclimation showed better adherence to CPAP therapy after one month, averaging 5.7 hours per night compared to 3.9 hours in the usual care group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we enhance compliance to treatment by performing a continuous positive airway pressure trial in obstructive sleep apnea? Parmaksız, ET.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10699648/

The effect of light therapy on sleep disorders and ...

Light therapy leads to significant improvement in sleep and psychobehavioral symptoms and is associated with relatively fewer side effects in patients with AD.

2.

jcsm.aasm.org

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

Bright light therapy for CPAP-resistant OSA symptoms

Patients experienced greater reductions in wake after sleep onset and increased amplitude of rest-activity rhythms in a shorter photoperiod with BLT compared ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11696139/

A systematic review and meta-analysis on light therapy for ...

The results showed that light therapy significantly improved the total sleep time (TST) (MD = 32.54, p < 0.00001) and sleep efficiency (SE) (MD ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2821240

Bright Light Exposure, Depression Symptoms, and Sleep ...

Bright light therapy can be effective at improving numerous mood outcomes, possibly through effects on sleep and the circadian system. Sleep ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1087079224000297

Bright light therapy has a positive effect on sleep quality in ...

Compared with the control group, BLT overall resulted in significant improvements in terms of sleep quality [g = −0.34], total sleep time [g = 0.24], wake after ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04299009?tab=table

Bright Light Therapy for Residual Daytime Symptoms ...

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea ... exposure to bright light has beneficial effects on sleep ...

7.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00053-1/fulltext

Efficacy of biologically-directed daylight therapy on sleep ...

We demonstrate that the controlled daylight significantly improved non-motor symptoms (restorative deep sleep, affect) and wellbeing, with the ...

8.

sleepfoundation.org

sleepfoundation.org/light-therapy

Light Therapy for Insomnia Sufferers

Light therapy can help relieve sleep issues associated with insomnia, circadian rhythm sleep disorders, jet lag, seasonal affective disorder, ...