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Набор скоро начнётся NCT02919189

Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 5 of 7)

Без фазы С лечением Exposure to Man-made Visible Light

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Visible light exposure.
Кому может быть актуально
Состояния в реестре: Exposure to Man-made Visible Light. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach

Обзор

NOTE: This is the fifth of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies. General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.

Вмешательства

  • Другое Visible light exposure
    Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by fluorescent light lamps.

Первичные конечные точки

  • Change in cerebral tissue oxygen saturation during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change in cerebral hemoglobin concentration during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change in variables of the heart rate variability during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change in electro-dermal activity during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the blood pressure during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the partial pressure of carbon dioxide during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the respiration rate during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the heart rate during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the pulse-respiratory quotient during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]
  • Change of the arterial oxygen saturation during colored light exposure compared with a baseline and a recovery period [Срок оценки: 43 minutes (8 min baseline, 15 min colored light exposure, 20 min recovery)]

Критерии участия

Критерии включения

  • Normal color vision
  • Right handed
  • Written informed consent

Критерии исключения

  • Smoking
  • Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
  • Acute severe traumas
  • Chronic diseases with the necessity for medication
  • Use of recreational drugs
  • Regular intake of medication that would affect the outcome measures
  • Regular excessive alcohol use (> 18 standard units / week)
  • Transmeridian travel in the last month (crossed > 1 time zone border)
  • Night shift word during the last month

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Швейцария · 1 центр
  • University of Bern, Institute of Complementary Medicine — Bern

Публикации

  • Weinzirl J, Wolf M, Nelle M, Heusser P, Wolf U. Colored light and brain and muscle oxygenation. Adv Exp Med Biol. 2012;737:33-6. doi: 10.1007/978-1-4614-1566-4_5. No abstract available. PMID 22259078
  • Weinzirl J, Wolf M, Heusser P, Nelle M, Wolf U. Effects of changes in colored light on brain and calf muscle blood concentration and oxygenation. ScientificWorldJournal. 2011 Jun 9;11:1216-25. doi: 10.1100/tsw.2011.118. PMID 21666991

Идентификаторы

NCT: NCT02919189 · COLOR10_e

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗