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| Name | Class |
|---|---|
| Flinn Foundation | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Lighting Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambient Lighting Condition | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Sharp, PhD | Contact | 480-965-6536 | nina.sharp@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nina Sharp, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASU DeSmart Lab | Recruiting | Tempe | Arizona | 85281 | United States |
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.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020795 | Photophobia |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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This is a single-arm, repeated-measures interventional study. All participants will complete a 4-week baseline observation period during which daily light exposure, sleep patterns, and migraine characteristics are monitored under naturalistic conditions. This will be followed by a 4-week intervention period during which an optimized workplace lighting condition will be introduced. Participants will continue wearable monitoring and daily electronic surveys throughout both phases. Outcomes during the intervention period will be compared to each participant's baseline measurements.
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|
| 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. |
| 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. | 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. | 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. | 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. | 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. | Baseline (Weeks 1-4) vs Intervention (Weeks 5-8) |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |