Narrow Band Green Light and Migraine

Migraine Clinical Trial

Official title:

A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841083
• Other study ID #: ALL-20-01
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2022
• Source: Vedanta Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 5, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with headaches or migraines.

Exclusion Criteria:

• Not having headaches or migraines

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Device:
• Allay Lamp
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).

Locations

Country	Name	City	State
United States	Vendata Research	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vedanta Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of headache days per week	Number of days with headache per week without and with using the Allay lamp	Change from baseline at 6 weeks
Primary	Change in number of headache days per month	Number of days with headache per month without and with using the Allay lamp	Changes from baseline at weeks 3-6 of using the Allay lamp
Primary	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.	Changes from baseline at 6 weeks of using the Allay Lamp.
Primary	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.	Changes from baseline at 6 weeks of using the Allay lamp