Идёт набор NCT07476053

Light Exposure, Migraine Outcomes, and Sleep Quality

Без фазы С лечением Migraine Headache Sleep Photophobia

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: Ambient Lighting Condition.
Кому может быть актуально: Состояния в реестре: Migraine Headache, Sleep, Photophobia. Базовые параметры: от 18 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: США
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

Daily Light Exposure Patterns and Their Associations With Migraine Outcomes and Sleep Quality

Обзор

Подробное описание

Migraine is a prevalent neurological disorder that significantly reduces quality of life and daily functioning. Photophobia, or heightened sensitivity to light, is one of the most common and distressing symptoms experienced by individuals with migraine and is frequently reported as a trigger or exacerbating factor for migraine attacks. Additionally, sleep disturbances are commonly associated with migraine and may both contribute to and result from migraine episodes. Despite growing evidence linking light exposure, sleep quality, and migraine characteristics, the role of daily light exposure characteristics in triggering migraine attacks remains poorly understood.

Previous research has largely focused on controlled laboratory studies examining the effects of specific light spectra or intensities during migraine attacks. However, little is known about how individuals with migraine experience and interact with light throughout their daily lives, or how these real-world exposure patterns relate to sleep quality and migraine onset, frequency, and severity.

The purpose of this study is to examine the relationship between daily light exposure patterns, sleep quality, and migraine characteristics in adults with migraine, with and without photophobia, across an 8-week study period. The first 4 weeks will serve as a baseline observational period in which participants' daily light exposure behaviors, sleep patterns, and migraine characteristics are monitored. The second four weeks will include the introduction of an interventional lighting condition, optimized for those in migraine based on our previous in-laboratory experiment, on the same outcomes (migraine characteristics and sleep).

Using wearable light exposure sensors, actigraphy devices, and daily self-reported measures, this study aims to capture real-world lighting behaviors and objectively assess sleep quality while evaluating whether the introduction of an optimized lighting condition is associated with changes in migraine symptoms and sleep outcomes.

The specific aims of this study are to:

1. Characterize daily light exposure patterns, including intensity, spectrum, duration, and related behavioral patterns, in adults with migraine with and without photophobia. 2. Examine associations between daily light exposure characteristics and migraine attack onset, frequency, and intensity. 3. Evaluate the feasibility and effectiveness of an optimized lighting condition on migraine frequency, migraine characteristics, and sleep quality.

Вмешательства

Другое Ambient Lighting Condition
Application of an optimized ambient lighting condition through placement of a dimmable LED floor lamp in participants' private workspaces to create a standardized workplace lighting environment during working hours. The floor lamp emits white light with a specified spectral distribution and intensity. Participants may adjust brightness for comfort. The lighting system is used solely to modify the ambient workplace lighting environment during the 4-week intervention period.

Первичные конечные точки

Change in Monthly Migraine Days [Срок оценки: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)]

Вторичные конечные точки (7)

Change in Migraine Headache Intensity [Срок оценки: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)]
Change in Migraine-Specific Quality of Life (MSQ v2.1) Score [Срок оценки: Baseline (Week 0), Between Baseline and Intervention (end of Week 4), and End of Intervention (Week 8).]
Change in Objective Sleep Efficiency [Срок оценки: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)]
Change in Average Daily Ambient Light Intensity [Срок оценки: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)]
Feasibility of Workplace Lighting Intervention [Срок оценки: Intervention Period (Weeks 5-8)]
Change in Objective Nighttime Sleep Duration [Срок оценки: Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)]
Change in Average Daily Melanopic Equivalent Daylight Illuminance [Срок оценки: Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)]

Критерии участия

Критерии включения

Meet the International Classification of Headache Disorders, 3rd edition (2018) criteria for migraine, with or without aura or photosensitivity
Report experiencing more than 4 headache days per month and at least three migraine attacks per month
No other major health issues based on self-reported data
Able to read and communicate in English
Work in a private office space for at least six hours per day, four days per week