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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light therapy can reduce excessive daytime sleepiness in people with Prader-Willi Syndrome, a condition known for causing constant hunger and sleep issues. Participants will receive either real light therapy or a placebo (fake treatment) to compare effects. It suits those diagnosed with Prader-Willi Syndrome, confirmed through genetic tests, who often feel very sleepy during the day. Participants should not have eye conditions affected by bright light or have used similar light treatments before. As an unphased trial, this study offers a unique opportunity to contribute to understanding potential new treatments for Prader-Willi Syndrome.

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 prior data suggests that Bright Light Therapy is safe for Prader-Willi Syndrome?

Studies have shown that bright light therapy is generally well-tolerated. Research indicates that for conditions like depression, it often causes mild side effects such as headaches or eye strain. These effects are usually temporary and not serious. Bright light therapy has been used safely in many situations, suggesting it could be a safe option for those with Prader-Willi Syndrome who experience excessive daytime sleepiness. However, as with any treatment, monitoring for side effects and discussing them with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bright light therapy for Prader-Willi Syndrome because it offers a non-invasive approach to managing symptoms. Unlike traditional treatments that often focus on medication to regulate hormones and appetite, bright light therapy uses exposure to specific light wavelengths to potentially influence sleep patterns and mood. This method is appealing because it avoids the side effects associated with pharmaceuticals, and it could offer a complementary option that enhances overall patient well-being.

What evidence suggests that Bright Light Therapy is effective for excessive daytime sleepiness in Prader-Willi Syndrome?

This trial will compare Bright Light Therapy (BLT) with Sham Light therapy. Research has shown that BLT might reduce excessive daytime sleepiness, especially in individuals with Prader-Willi Syndrome. Light therapy can regulate sleep patterns, increasing daytime alertness. In other conditions, such as nonseasonal depression, BLT significantly reduces symptoms, suggesting it might also enhance alertness. These findings support the potential of BLT in managing sleepiness in Prader-Willi Syndrome. ^{1 2 3 4 5}

Who Is on the Research Team?

Deepan Singh, MD

Principal Investigator

Maimonides Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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]

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 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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05939453

Impact of Bright Light Therapy on Prader-Willi Syndrome

This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients ...

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centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05939453/impact-of-bright-light-therapy-on-prader-willi-syndrome

Impact of Bright Light Therapy on Prader-Willi Syndrome

This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness ...

3.

fpwr.org

fpwr.org/fpwr-funded-projects/impact-of-bright-light-therapy-on-all-cause-excessive-daytime-sleepiness-in-prader-willi-syndrome

Impact of Bright Light Therapy on All-Cause Excessive ...

Light exposure might have a modulating effect on the sleep abnormalities noted in PWS. Light therapy (LT) utilizing appropriately timed exposure to an ...

4.

withpower.com

withpower.com/trial/phase-prader-willi-syndrome-6-2023-118b7

Bright Light Therapy for Prader-Willi Syndrome

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

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10371899/

High levels of LIGHT/TNFSF14 in patients with Prader–Willi ...

The present study aimed to evaluate LIGHT serum levels in 28 children and 52 adult PWS patients compared to age and sex-matched controls, as ...