What side effects are associated with this type of intervention?

Common treatments for behavioral sleep issues, such as light therapy, generally have minimal side effects. Light therapy, which involves exposure to bright light to influence circadian rhythms and improve alertness, is typically well-tolerated. Some patients may experience mild side effects such as eye strain, headache, nausea, or irritability. These side effects are usually temporary and can often be mitigated by adjusting the duration or intensity of light exposure. Strategic avoidance of evening light, such as using amber or blue-blocker glasses, has no significant risks but may not address all stimulating effects from media devices.

What prior FDA approvals exist?

The FDA has approved several treatments for behavioral issues that influence circadian rhythms and improve alertness. For instance, melatonin is commonly used to treat sleep disorders by regulating the sleep-wake cycle, although it is considered a dietary supplement rather than a drug. Additionally, medications like methylphenidate and lisdexamfetamine are approved for attention-deficit/hyperactivity disorder (ADHD) and can improve alertness and behavioral control. These treatments, while not identical to light therapy, share the goal of enhancing alertness and managing behavioral symptoms.

What other types of research exist?

Promising alternatives to light therapy for influencing circadian rhythms and improving alertness include: 1) Melatonin administration, which has shown efficacy in advancing sleep onset and improving sleep quality in both children and adults with circadian rhythm disorders. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has demonstrated positive effects on cognitive functions and sleep parameters, particularly in adolescents. 3) Pharmacologic treatments, particularly in children with neurologic and developmental disorders, where melatonin combined with behavioral interventions has been effective in reducing sleep onset latency and improving daytime behavior.

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Behavioural Intervention

Bright Light Therapy for Prader-Willi Syndrome (PWS-LT Trial)

N/A

Recruiting

Led By Deepan Singh, MD

Research Sponsored by Maimonides Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PWS confirmed by genetic testing

Be younger than 65 years old

Must not have

Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications

A history of previous treatment with LT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Bright Light Therapy may cause eyestrain, headache, nausea, irritability or agitation especially in those sensitive to light. However, specific side effects will be monitored as this is part of what the study aims to discover.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have been treated with LT before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Global Impression- Improvement (CGI-I)

Secondary study objectives

Aberrant Behavior Checklist

Modified Overt Aggression Scale

Self-Injury Trauma scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Light TherapyExperimental Treatment1 Intervention

Group II: Sham LightPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for behavioral issues, particularly those affecting sleep and circadian rhythms, include light therapy and cognitive-behavioral therapy (CBT). Light therapy involves exposure to bright light, which helps to reset the body's internal clock, thereby improving sleep patterns and daytime alertness. This is particularly effective for conditions like Seasonal Affective Disorder (SAD) and Delayed Sleep-Wake Phase Disorder (DSWPD). CBT, on the other hand, addresses the psychological aspects by helping patients develop healthier sleep habits and coping strategies. These treatments are crucial as they target both the physiological and psychological components of sleep disturbances, leading to more comprehensive and sustained improvements in patient outcomes.

Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial.Cognitive-behavioral therapy, light therapy, and their combination in treating seasonal affective disorder.Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia.