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

Trial Summary

What is the purpose of this trial?

Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.

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 data supports the effectiveness of the treatment Bright Light Therapy for Sleep Apnea?

A study on bright light therapy (BLT) showed it might help improve sleep and reduce daytime sleepiness in people with sleep apnea who don't fully benefit from CPAP (a common sleep apnea treatment). This suggests BLT could be a useful addition to managing sleep apnea symptoms. ^{1 2 3 4 5}

Is bright light therapy safe for humans?

Bright light therapy (BLT) is generally well-tolerated with few side effects. Some studies report minor issues like blurring, but serious side effects are rare, making it a safe option for many people. ^{6 7 8 9 10}

How is bright light therapy different from other treatments for sleep apnea?

Bright light therapy is unique because it uses exposure to bright light to help align sleep-wake cycles, which can be beneficial for conditions with disrupted circadian rhythms. Unlike other treatments for sleep apnea that may involve devices or medications, this therapy focuses on adjusting the body's internal clock through light exposure, making it a non-invasive option. ^{6 7 10 11 12}

Research Team

Isabella Soreca, MD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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]

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) 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]

References

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

Bright light therapy for CPAP-resistant OSA symptoms. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Redefining the timing of surgery for obstructive sleep apnea in anatomically favorable patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Treatment outcome of sleep apnea. [2007]

6. Poland pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. [2018]

10. Switzerland 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. [2016]

11. France pubmed.ncbi.nlm.nih.gov

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

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

Feasibility of Adjunctive Bright Light Therapy for Depressive Symptoms on an Acute Psychiatric Floor. [2023]