Recruiting

Bright Light Therapy

Sponsor:

Maimonides Medical Center

Code:

NCT05939453

Conditions

Prader-Willi Syndrome

Excessive Daytime Sleepiness

Hyperphagia

Body Weight

Mood

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

Interventions

Sham Light

Bright Light Therapy

Study Details

Brief summary:

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

Conditions

Prader-Willi Syndrome

Excessive Daytime Sleepiness

Hyperphagia

Body Weight

Mood

Study ID

NCT05939453

Start date

Oct 1, 2023

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Light

experimental: Light Therapy

Interventions

Sham Light

Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.

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.

Primary outcome measure

  • Clinical Global Impression- Improvement (CGI-I) [ Time Frame: 8 Weeks ]

Central Contacts and Locations

Central contacts

Mayank Kumar, PhD

718-283-8170maykumar@maimo.org

Theresa Jacob, MPH, PhD

718-283-7162tjacob@maimonidesmed.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Theresa Jacob, PhD, MPH

718-283-8170tjacob@maimo.org

Hasan Mustafic, BA

718-283-8170hmustafic@maimo.org

Principal Investigator:

Edward Yi, MD

More Information

Sponsor

Maimonides Medical Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maimonides Medical Center on 2026-05-15.