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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
PWS-LT Trial Summary
This trial tests if light therapy can help reduce excessive daytime sleepiness in people with Prader-Willi Syndrome.
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.Check my eligibility
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.See study design
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.
PWS-LT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Prader-Willi Syndrome diagnosis was confirmed through genetic testing.
PWS-LT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Global Impression- Improvement (CGI-I)
Secondary outcome measures
Aberrant Behavior Checklist
Modified Overt Aggression Scale
Self-Injury Trauma scale
PWS-LT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Light TherapyExperimental Treatment1 Intervention
Group II: Sham LightPlacebo Group1 Intervention
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.
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.
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Who is running the clinical trial?
Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,265 Total Patients Enrolled
Foundation for Prader-Willi ResearchOTHER
13 Previous Clinical Trials
1,158 Total Patients Enrolled
Deepan Singh, MDPrincipal InvestigatorMaimonides Medical Center
4 Previous Clinical Trials
155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an eye condition sensitive to bright light or take medication that increases light sensitivity.I have been treated with LT before.My Prader-Willi Syndrome diagnosis was confirmed through genetic testing.You have a high score on the Epworth Sleepiness Scale, indicating excessive daytime sleepiness.You are currently experiencing severe mental health issues like hallucinations or extreme mood swings.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Light
- Group 2: Light Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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