Back to resultsNarrow Band Green Light and Migraine
Primary Purpose
Migraine, Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allay Lamp
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Adults with headaches or migraines.
Exclusion Criteria:
- Not having headaches or migraines
Sites / Locations
- Vendata Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allay lamp (narrow band green light)
Arm Description
Subjects who purchased the Allay Lamp are asked to document the effects of spending time in the narrow band of green light it emits, on their headache or any of its associated symptoms.
Outcomes
Primary Outcome Measures
Change in number of headache days per week
Number of days with headache per week without and with using the Allay lamp
Change in number of headache days per month
Number of days with headache per month without and with using the Allay lamp
Change in frequency of experiencing photophobia
Assessing frequency of photophobia during days with headache as depicted by participants using the following options: (1)never, rarely, (2)less than half, (3)half or more, (4)nearly all the time.
Change in headache severity
Assessing headache severity while using the Allay lamp. Improvement is determined by the number of times participants answer Yes or NO in their daily diary.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04841083
Brief Title
Narrow Band Green Light and Migraine
Official Title
A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vedanta Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allay lamp (narrow band green light)
Arm Type
Experimental
Arm Description
Subjects who purchased the Allay Lamp are asked to document the effects of spending time in the narrow band of green light it emits, on their headache or any of its associated symptoms.
Intervention Type
Device
Intervention Name(s)
Allay Lamp
Intervention Description
The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10 lux) narrow band (20 nm) green light (peak wavelength 520 nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k).
Primary Outcome Measure Information:
Title
Change in number of headache days per week
Description
Number of days with headache per week without and with using the Allay lamp
Time Frame
Change from baseline at 6 weeks
Title
Change in number of headache days per month
Description
Number of days with headache per month without and with using the Allay lamp
Time Frame
Changes from baseline at weeks 3-6 of using the Allay lamp
Title
Change in frequency of experiencing photophobia
Description
Assessing frequency of photophobia during days with headache as depicted by participants using the following options: (1)never, rarely, (2)less than half, (3)half or more, (4)nearly all the time.
Time Frame
Changes from baseline at 6 weeks of using the Allay Lamp.
Title
Change in headache severity
Description
Assessing headache severity while using the Allay lamp. Improvement is determined by the number of times participants answer Yes or NO in their daily diary.
Time Frame
Changes from baseline at 6 weeks of using the Allay lamp
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with headaches or migraines.
Exclusion Criteria:
Not having headaches or migraines
Facility Information:
Facility Name
Vendata Research
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
12. IPD Sharing Statement
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Narrow Band Green Light and Migraine
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