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Набира участници Не е приложимо NCT05939453

Impact of Bright Light Therapy on Prader-Willi Syndrome

Не е приложима фаза (напр. обсервационно)
Заболявания: Prader-Willi Syndrome Excessive Daytime Sleepiness Hyperphagia Body Weight Mood Behavior

Спонсор: Maimonides Medical Center

Налично на: БГ
Обобщение
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
Описание
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.
Кой може да участва
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
Интервенции
Sham Light
OTHER
Bright Light Therapy
OTHER
Места на провеждане 1
САЩ (1)
Maimonides Medical Center
Brooklyn , New York
Theresa Jacob, PhD, MPH
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
6 Years
Максимална възраст
88 Years
Здрави доброволци
Не
Начална дата
01.10.2023
Крайна дата
01.12.2026
Регистрационен номер
NCT05939453
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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