- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07476053
Light Exposure, Migraine Outcomes, and Sleep Quality
Daily Light Exposure Patterns and Their Associations With Migraine Outcomes and Sleep Quality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Characterize daily light exposure patterns, including intensity, spectrum, duration, and related behavioral patterns, in adults with migraine with and without photophobia.
- Examine associations between daily light exposure characteristics and migraine attack onset, frequency, and intensity.
- Evaluate the feasibility and effectiveness of an optimized lighting condition on migraine frequency, migraine characteristics, and sleep quality.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nina Sharp, PhD
- Phone Number: 480-965-6536
- Email: nina.sharp@asu.edu
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85281
- Recruiting
- ASU DeSmart Lab
-
Contact:
- Nina Sharp, PhD
- Phone Number: 480-965-6536
- Email: nina.sharp@asu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Light therapy
- Use light-altering devices (e.g., blue-blocking contact lenses or glasses)
- Traveling out of town during the participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Optimized Lighting Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Monthly Migraine Days
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.
|
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Migraine Headache Intensity
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.
|
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
|
|
Change in Migraine-Specific Quality of Life (MSQ v2.1) Score
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.
|
Baseline (Week 0), Between Baseline and Intervention (end of Week 4), and End of Intervention (Week 8).
|
|
Change in Objective Sleep Efficiency
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.
|
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
|
|
Change in Average Daily Ambient Light Intensity
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.
|
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)
|
|
Feasibility of Workplace Lighting Intervention
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.
|
Intervention Period (Weeks 5-8)
|
|
Change in Objective Nighttime Sleep Duration
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.
|
Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)
|
|
Change in Average Daily Melanopic Equivalent Daylight Illuminance
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.
|
Baseline (Weeks 1-4) vs Intervention (Weeks 5-8)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nina Sharp, PhD, Arizona State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00023649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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