An interventional study of Ambient Lighting Condition in Migraine Headache, Sleep and Photophobia, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Arizona State University · Not applicable, Interventional, and Other
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.
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:
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
All participants will complete a 4-week baseline observation period followed by a 4-week intervention period. During the baseline period, daily light exposure, sleep, and migraine characteristics will be monitored under natural conditions. During the intervention period, participants will use an optimized workplace lighting condition during working hours while continuing wearable monitoring and daily electronic surveys. Outcomes during the intervention period will be compared to baseline measurements within participants.
Other: 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.
Change in Monthly Migraine Days
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)
Change in Migraine Headache Intensity
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 (Weeks 1-4) compared to Intervention (Weeks 5-8)
Change in Migraine-Specific Quality of Life (MSQ v2.1) Score
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 (Week 0), Between Baseline and Intervention (end of Week 4), and End of Intervention (Week 8).
Change in Objective Sleep Efficiency
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)
Change in Average Daily Ambient Light Intensity
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: Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
Feasibility of Workplace Lighting Intervention
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: Intervention Period (Weeks 5-8)
Change in Objective Nighttime Sleep Duration
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)
Change in Average Daily Melanopic Equivalent Daylight Illuminance
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.
Time frame: Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)
Plan to share: Undecided — Individual participant data (IPD) sharing has not yet been determined. De-identified data may be considered for sharing with qualified researchers following publication of primary study results, subject to institutional policies, data use agreements, and protection of participant confidentiality. Decisions regarding data sharing will take into account future research plans.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 12 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
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