ASU DeSmart Lab
Tempe, Arizona, 85281, United States
Location status: Recruiting
NCT Number: NCT07476053
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tempe, Arizona, 85281, United States
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
Number of migraine days per 28-day period as recorded in daily electronic headache diaries. A migraine day is defined as a calendar day with a self-reported migraine meeting International Classification of Headache Disorders (ICHD-3) criteria. The primary analysis will compare the 4-week baseline period to the 4-week intervention period within participants.
Time frame: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
Average migraine pain intensity recorded in daily electronic headache diaries using a numerical rating scale (e.g., 0-10). Mean intensity during the 4-week baseline period will be compared to the 4-week intervention period within participants.
Time frame: Baseline (Week 0), Between Baseline and Intervention (end of Week 4), and End of Intervention (Week 8).
Change in total and domain scores on the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1). Higher scores indicate better quality of life. Scores at baseline will be compared to scores at Week 8.
Time frame: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
Sleep efficiency measured by wrist-worn actigraphy, defined as the percentage of time in bed spent asleep. Average sleep efficiency during the 4-week baseline period will be compared to the 4-week intervention period.
Time frame: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
Average daily ambient light intensity (lux) measured using a wearable light sensor. Daily mean illuminance (lux) will be calculated for each participant and averaged across the 4-week baseline period and the 4-week intervention period. The primary comparison is baseline versus intervention within participants.
Time frame: Intervention Period (Weeks 5-8)
Feasibility assessed by adherence to lighting use, defined as average number of hours per workday the intervention lighting was used during the 4-week intervention period, based on participant self-report.
Time frame: Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)
Average nightly total sleep time (minutes) measured by wrist-worn actigraphy. Nighttime sleep duration will be calculated for each night using actigraphy-defined sleep intervals (supplemented by the Consensus Sleep Diary to define time-in-bed). The primary comparison is the mean nightly sleep duration during the 4-week baseline period versus the 4-week intervention period within participants.
Time frame: Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)
Average daily melanopic equivalent daylight illuminance (melanopic EDI, lux) derived from full spectral power distribution measurements (350-780 nm) recorded by a wearable light sensor. Values will be averaged across the 4-week baseline and 4-week intervention periods and compared within participants.
Contact information is provided by the study sponsor or research team.
Arizona State University
Other
Daily Light Exposure Patterns and Their Associations With Migraine Outcomes and Sleep Quality
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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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