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NCT Number: NCT05939453

Impact of Bright Light Therapy on 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

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Behavior Body Weight Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Genetic Diseases, Inborn Hyperphagia Imprinting Disorders Intellectual Disability Mental Disorders Mood Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

6 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location status: Recruiting

Location contact

Edward Yi, MD

PRINCIPAL_INVESTIGATOR

Hasan Mustafic, BA

CONTACT

[email protected]

718-283-8170

Theresa Jacob, MPH, PhD

SUB_INVESTIGATOR

Theresa Jacob, PhD, MPH

CONTACT

[email protected]

718-283-8170

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Light

Other

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

Bright Light Therapy

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Aberrant Behavior Checklist

    Time frame: 8 Weeks

    Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mayank Kumar, PhD

CONTACT

[email protected]

718-283-8170

Theresa Jacob, MPH, PhD

CONTACT

[email protected]

718-283-7162

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Collaborators

  • Foundation for Prader-Willi Research

Registry information

Official study title

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

Acronym: PWS-LT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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