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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 below

Select...

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

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

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

0 / 1Eligibility criteria met

Find a Location

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

Bright Light Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05939453 — N/A

Behavior Research Study Groups: Sham Light, Light Therapy

Behavior Clinical Trial 2023: Bright Light Therapy Highlights & Side Effects. Trial Name: NCT05939453 — N/A

Bright Light Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05939453 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is allowed to join in on this investigation?

"To qualify for this clinical trial, applicants must have Prader-Willi Syndrome and be between the ages of 6 to 18. The research team intends to recruit 30 participants in total."

Answered by AI

Are there still opportunities for patient participation in this clinical experimentation?

"As evidenced by clinicaltrials.gov, this particular study is now closed to new participants, having been initially posted on July 1st 2023 and last updated a day later. However, 1649 other medical trials are currently recruiting patients throughout the world."

Answered by AI

Does the current research encompass individuals who are over 40 years of age?

"Interested participants must satisfy the age-range requirements of 6 to 18 years old. The trial registry contains 423 other studies that involve minors and 1134 trials for seniors over 65."

Answered by AI