RECRUITING

Impact of Bright Light Therapy on Prader-Willi Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05939453

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.

Ages Eligible for Study:6 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of PWS confirmed by genetic testing
  2. * Score of 12 or above on the Epworth Sleepiness Scale (ESS).
  1. * 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
  2. * A history of previous treatment with LT
  3. * Patients presenting with active psychosis or mania

Contacts and Locations

Study Contact

Otuwe Anya, BA
CONTACT
718-283-8170
oanya@maimonidesmed.org
Theresa Jacob, MPH, PhD
CONTACT
718-283-7162
tjacob@maimonidesmed.org

Principal Investigator

Deepan Singh, MD
PRINCIPAL_INVESTIGATOR
Maimonides Medical Center

Study Locations (Sites)

Maimonides Medical Center
Brooklyn, New York, 11219
United States

Collaborators and Investigators

Sponsor: Maimonides Medical Center

  • Deepan Singh, MD, PRINCIPAL_INVESTIGATOR, Maimonides Medical Center

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 Registration Dates

Study Start Date2023-10-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Light Therapy
  • Aberrant Behavior Checklist
  • Clinical Global Impression- Improvement
  • Fitbit
  • Actigraphy reports
  • Epworth Sleepiness Scale
  • Hyperphagia Questionnaire (HQCT)
  • Modified Overt Aggression Scale (MOAS)

Additional Relevant MeSH Terms

  • Prader-Willi Syndrome
  • Excessive Daytime Sleepiness
  • Hyperphagia
  • Body Weight
  • Mood
  • Behavior