Impact of Bright Light Therapy on Prader-Willi Syndrome

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Maimonides Medical Center
Study ID
NCT05939453
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Oct 1, 2023
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Light
  • Experimental: Light Therapy

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Theresa Jacob, PhD, MPH
[email protected]
718-283-8170
Hasan Mustafic, BA
[email protected]
718-283-8170
Theresa Jacob, MPH, PhD (SUB_INVESTIGATOR)
Edward Yi, MD (PRINCIPAL_INVESTIGATOR)

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