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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.

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 data supports the effectiveness of the treatment Light Therapy for Sleep Disorders and Cognitive Impairment?

Research shows that light therapy can help improve sleep and mood disorders, including insomnia and seasonal affective disorder. It has also been noted to aid cognitive improvement in conditions like dementia and attention deficit hyperactivity disorder. ^{1 2 3 4 5}

Is light therapy safe for humans?

Light therapy, also known as phototherapy or bright light therapy, is generally considered safe for humans. It has been used for various conditions like sleep disorders and mood disorders, with studies indicating no significant side effects compared to other treatments. ^{1 2 4 6 7}

How does light therapy differ from other treatments for sleep disorders and cognitive impairment?

Light therapy is unique because it uses bright light exposure to adjust the body's internal clock, helping to improve sleep patterns and mood without medication. It is particularly effective for conditions where circadian rhythms (the body's natural sleep-wake cycle) are disrupted, and it offers a non-drug alternative with minimal side effects. ^{1 2 3 4 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

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

Illuminating rationale and uses for light therapy. [2021]

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

[The current state of research in bright light therapy]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Evolving applications of light therapy. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Light therapy in insomnia disorder: A systematic review and meta-analysis. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. [2004]

7. France pubmed.ncbi.nlm.nih.gov

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