Light Therapy for Sleep Disorders and Cognitive Impairment

Overseen By Renske Lok, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stanford University

Disqualifiers: Severe depression, Unstable disease, Infection

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if bright light exposure can improve sleep and cognitive issues in older adults. It examines how morning and afternoon light therapy (also known as phototherapy or bright light therapy) might reduce sleep troubles, such as frequent nighttime awakenings, in those with mild cognitive impairment. Participants will receive daily light exposure either in the morning or afternoon. This trial suits individuals over 65 with mild cognitive impairment who do not have severe depression or unstable health issues. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for light therapy?

Research shows that light therapy is generally safe for treating sleep problems. Studies have found that it can improve sleep and thinking skills with few side effects. For instance, one study found that light therapy helped people sleep longer and better. Another study emphasized its safety and the absence of medication, making it a good choice for improving sleep and mood. Overall, light therapy is well-tolerated, and many people benefit from it with minimal risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about light therapy for sleep disorders and cognitive impairment because it offers a non-invasive, drug-free approach to treatment. Unlike medications that often have side effects and take weeks to work, light therapy can show benefits quickly by simply using timed exposure to bright light. The unique aspect of the study is comparing two different timings for light exposure, which may help fine-tune the therapy to maximize benefits for sleep and cognitive function. This could lead to a more personalized and effective treatment option for those struggling with these conditions.

What evidence suggests that light therapy could be effective for sleep disorders and cognitive impairment?

Research has shown that light therapy can improve sleep and brain function. One study found that light therapy increased sleep efficiency and total sleep time, both crucial for better rest. Another study found that light therapy improved thinking skills and reduced depression in people with dementia. Bright light therapy is also linked to a 41% remission rate in nonseasonal depression, highlighting its broader potential benefits. In this trial, participants will receive either standard care with morning light exposure or stepped care with afternoon light exposure. These findings suggest that afternoon light therapy may help manage sleep problems and cognitive issues. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals over the age of 65 who are experiencing mild cognitive impairment. It's not suitable for those with unstable psychiatric or medical conditions, severe depression, or an acute infection.

Inclusion Criteria

I am older than 65.

Mild Cognitive Impairment

Exclusion Criteria

I do not have any unstable mental or physical health conditions.

I have been diagnosed with severe depression.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation

4 weeks

Daily visits for light exposure

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Light therapy

Trial Overview The study is testing whether scheduled bright light therapy in the morning and afternoon can help improve sleep quality and reduce sleep fragmentation in older adults with mild cognitive impairment.

How Is the Trial Designed?

Group I: Stepped care Experimental Treatment 1 Intervention

One hour of daily bright light exposure in the afternoon

Group II: Standard of care Active Control 1 Intervention

One hour of daily bright light exposure beginning one hour after wake time.

Light therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal Major Depressive Disorder (MDD)

Approved in European Union as Phototherapy for:

• Seasonal Affective Disorder (SAD)
• Circadian Rhythm Disorders

Approved in Canada as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal Major Depressive Disorder (MDD)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 42 patients with major depressive disorder, both bright white-light therapy (2,500 lux) and dim red-light therapy (50 lux) were administered daily for seven days without any significant differences in side effects between the two treatments.

This suggests that light therapy, regardless of intensity, may be a safe option for treating depression without increasing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. Volz, HP., Mackert, A., Stieglitz, RD.[2004]

Bright light therapy is an established and effective treatment for seasonal affective disorder and has shown therapeutic benefits for various neurological and psychiatric disorders, including sleep disorders and dementia.

Recent clinical trials have reinforced the efficacy of bright light therapy, highlighting its importance in mental health treatment and prompting advancements in light engineering for improved therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The current state of research in bright light therapy]. Bassa, D., Canazei, M., Hinterhuber, H., et al.[2021]

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]

Light therapy is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

Light therapy is being used more frequently to treat various sleep and psychiatric conditions, such as circadian rhythm sleep disorders and seasonal affective disorder, highlighting its growing importance in clinical practice.

Understanding the neural mechanisms behind circadian rhythms is essential for leveraging light therapy effectively, as it can significantly influence brain function and improve mood and sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illuminating rationale and uses for light therapy. Shirani, A., St Louis, EK.[2021]

Light therapy, originally developed for seasonal affective disorder (SAD), has shown efficacy not only for SAD but also for other psychiatric conditions, including nonseasonal major depressive disorder and bipolar depression, particularly in cases resistant to traditional treatments.

Recent studies suggest that light therapy can improve cognitive function in adults with ADHD, enhance motor function in Parkinson's disease, and alleviate rest-activity disturbances in elderly patients with dementia, indicating its broad therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving applications of light therapy. Terman, M.[2022]

Bright light therapy has been shown to significantly improve wake after sleep onset (WASO) in individuals with insomnia, based on a meta-analysis of 22 studies involving 685 participants.

While light therapy did not affect other sleep measures like sleep latency or total sleep time, it demonstrated potential for personalized treatment approaches by adjusting light exposure based on the type of insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy in insomnia disorder: A systematic review and meta-analysis. Chambe, J., Reynaud, E., Maruani, J., et al.[2023]

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748123005171

The Effects of Light Therapy on Sleep, Depression ... This meta-analysis demonstrates that light therapy is effective in improving sleep, cognition, and decreasing depression and neuropsychiatric behaviors for PLWD ...

3. nature.com nature.com/articles/s41598-024-83789-3

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. psychiatry.org psychiatry.org/news-room/apa-blogs/bright-light-therapy-beyond-seasonal-depression

Bright Light Therapy: Growing Evidence Beyond Seasonal ... The study found that bright light therapy was associated with a 41% remission rate in people with nonseasonal depression, significantly higher ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9645769/

Examining the Efficacy of Bright Light Therapy on Cognitive ... Several studies have shown that bright light therapy may improve cognition, potentially due to its effects on the circadian system via brain regions that ...

6. alzheimers.org.uk alzheimers.org.uk/about-dementia/treatments/alternative-therapies/light-therapy-and-dementia

Light therapy and dementia A large and well-conducted research review found that bright light therapy can result in less daytime sleeping and increased night-time sleeping. Current ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8677890/

Efficacy and safety evaluation of bright light therapy in patients ... Bright light therapy (BLT) is thought to be relatively safe and effective in treating PSI patients. Despite this, there is still a lack of systematic review on ...