Impact of Bright Light Therapy on Prader-Willi Syndrome (PWS-LT)

November 13, 2023 updated by: Maimonides Medical Center

A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis.

Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Theresa Jacob, MPH, PhD
        • Principal Investigator:
          • Deepan Singh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of PWS confirmed by genetic testing
  • Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Exclusion Criteria:

  • 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
  • Patients presenting with active psychosis or mania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Light
Other: Sham Light
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
Experimental: Light Therapy
Other: Bright Light Therapy
Bright Light Therapy will be provided using light box with an artificial full spectrum lamp at a distance of at least 70cm but no greater than 90cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression- Improvement (CGI-I)
Time Frame: 8 Weeks
A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aberrant Behavior Checklist
Time Frame: 8 Weeks
Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).
8 Weeks
Self-Injury Trauma scale
Time Frame: 8 Weeks
Scores of 5 or greater were found to be indicative of borderline personality disorder. Part 1 is ranking based on the number of wounds 1=one would (common in a mild self-injurious behavior but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Injury severity is scored on a subjective basis with labels such as "mild" "moderate" and "severe" accompanied by descriptions of the observed state of the anatomy. Part 3 is the Estimate of Current Risk.
8 Weeks
Modified Overt Aggression Scale
Time Frame: 8 Weeks
Four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes.[1] The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimonides Medical Center

Collaborators

Foundation for Prader-Willi Research

Investigators

  • Principal Investigator: Deepan Singh, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 2022-08-12-MMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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