Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine|
- HIT-6 Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being.
- Headache Frequency as Measured Using a Self-Reporting Daily Diary [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Headache frequency will be assessed using daily headache diary entries provided by subjects
- Headache Severity as Measured Using a Visual Analog Scale and a Self-Reported Daily Diary [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Subjects will rate the severity of their headaches throughout the study using a visual analog scale as part of a daily headache diary.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942486
|United States, Utah|
|Primary Childrens Medical Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Meghan Candee, MD||University of Utah|