Bright Light Therapy for Prader-Willi Syndrome

(PWS-LT Trial)

Overseen By Theresa Jacob, MPH, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Maimonides Medical Center

Must not be taking: Photosensitizing medications

Disqualifiers: Eye conditions, Psychosis, Mania, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if light therapy can reduce daytime sleepiness in children with Prader-Willi Syndrome by helping them feel more awake during the day and sleep better at night. Light therapy has been explored for daytime sleepiness and insomnia in various conditions, including Parkinson's disease and dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on photosensitizing medications (medications that make you more sensitive to light), you may not be eligible to participate.

What data supports the effectiveness of the treatment Bright Light Therapy for Prader-Willi Syndrome?

Research shows that Bright Light Therapy (BLT) can help improve mood and eating patterns in people with eating disorders and depression. It has been effective in reducing symptoms of night eating syndrome and improving mood in individuals with nonseasonal depression, suggesting it may have potential benefits for Prader-Willi Syndrome, which also involves mood and eating challenges. ^{1 2 3 4 5}

Is bright light therapy generally safe for humans?

Bright light therapy (BLT) is generally considered safe, with studies showing it is well-tolerated in healthy individuals and pregnant women. Some minor side effects like blurring have been reported, but serious side effects are rare. ^{1 3 6 7 8}

How does Bright Light Therapy differ from other treatments for Prader-Willi Syndrome?

Bright Light Therapy is unique because it is a noninvasive treatment that uses light exposure to potentially improve mood and regulate circadian rhythms (the body's internal clock), which may help with symptoms related to Prader-Willi Syndrome. Unlike other treatments that might focus on medication or dietary changes, this therapy involves exposure to bright light, which has been shown to help with mood and sleep disturbances in other conditions. ^{1 2 3 4 5}

Research Team

Deepan Singh, MD

Principal Investigator

Maimonides Medical Center

Eligibility Criteria

This trial is for individuals with Prader-Willi Syndrome who often feel very sleepy during the day and score at least 12 on a sleepiness scale. They must have their diagnosis confirmed genetically. It's not suitable for those with certain eye conditions, people taking light-sensitive medication, or anyone previously treated with light therapy.

Inclusion Criteria

My Prader-Willi Syndrome diagnosis was confirmed through genetic testing.

You have a high score on the Epworth Sleepiness Scale, indicating excessive daytime sleepiness.

Exclusion Criteria

I have an eye condition sensitive to bright light or take medication that increases light sensitivity.

I have been treated with LT before.

You are currently experiencing severe mental health issues like hallucinations or extreme mood swings.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bright light therapy or sham light therapy for excessive daytime sleepiness in Prader-Willi Syndrome

8 weeks

8 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bright Light Therapy
• Sham Light

Trial Overview The study is testing if bright light therapy can help reduce excessive daytime sleepiness in Prader-Willi Syndrome patients compared to a sham (fake) light treatment. Participants won't know which one they're getting to ensure the results are unbiased.

Participant Groups

Group I: Light Therapy Experimental Treatment 1 Intervention

Group II: Sham Light Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials

72

Recruited

15,400+

Foundation for Prader-Willi Research

Collaborator

Trials

14

Recruited

1,200+

Findings from Research

In a study of 24 female patients aged 15-20 with anorexia nervosa and depressive symptoms, those receiving bright light therapy (BLT) showed significantly greater improvement in depression symptoms after 5 and 6 weeks compared to those who only received cognitive behavioral therapy.

While both groups experienced similar increases in body mass index (BMI) after 6 weeks, the BLT group began to see improvements in BMI earlier, suggesting that BLT may enhance overall treatment effectiveness for depression in anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light treatment of depressive symptoms in patients with restrictive type of anorexia nervosa. Janas-Kozik, M., Krzystanek, M., Stachowicz, M., et al.[2018]

Bright light therapy shows potential as an effective treatment for improving disordered eating behaviors and mood in individuals with eating disorders, based on a systematic review of 14 studies.

The exact timing of symptom improvement and the duration of treatment effects are still unclear, indicating a need for further research to better understand how bright light therapy works and its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Bright Light Therapy for Eating Disorders. Beauchamp, MT., Lundgren, JD.[2022]

Bright light therapy (BLT) significantly reduces depressive symptoms in nonseasonal depression, with a standardized mean difference of -0.62 based on a review of nine trials.

BLT is particularly effective when administered for 2-5 weeks and as a standalone treatment, although its impact on perinatal depression remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. Al-Karawi, D., Jubair, L.[2018]

In a pilot trial involving 15 adults, two weeks of daily bright light therapy (10,000 lux) in the morning led to significant reductions in symptoms of night eating syndrome, mood disturbances, and sleep disturbances.

These results suggest that bright light therapy may be an effective treatment option for individuals suffering from night eating syndrome, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy for the treatment of night eating syndrome: A pilot study. McCune, AM., Lundgren, JD.[2018]

A 17-year-old girl with an atypical eating disorder showed significant improvement in mood and eating behaviors after starting bright light therapy, with her depression scores dropping from severe to mild/moderate within a month.

This case suggests that light therapy could be an effective treatment for young people with eating disorders that worsen during winter months, highlighting the need for controlled studies to further investigate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy in the clinical management of an eating-disordered adolescent with winter exacerbation. Ash, JB., Piazza, E., Anderson, JL.[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]

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) did not show a significant difference in seizure reduction between high-intensity and low-intensity light boxes in a study of 101 adults with focal epilepsy, suggesting that both intensities may have similar effects.

However, patients with hippocampal sclerosis showed a higher likelihood of responding positively to BLT, indicating that this treatment may be more beneficial for individuals with this specific type of brain pathology, while caution is advised for those with extra temporal focal epilepsy due to potential increased seizure activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy as an add on treatment for medically intractable epilepsy. Baxendale, S., O'Sullivan, J., Heaney, D.[2012]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Bright light treatment of depressive symptoms in patients with restrictive type of anorexia nervosa. [2018]

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

A Systematic Review of Bright Light Therapy for Eating Disorders. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Bright light therapy for the treatment of night eating syndrome: A pilot study. [2018]

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

Light therapy in the clinical management of an eating-disordered adolescent with winter exacerbation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Poland pubmed.ncbi.nlm.nih.gov

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

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

Bright light therapy as an add on treatment for medically intractable epilepsy. [2012]