Narrow Band Green Light and Migraine

December 6, 2022 updated by: Michael Reed, Vedanta Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Vendata Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with headaches or migraines.

Exclusion Criteria:

  • Not having headaches or migraines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allay lamp (narrow band green light)
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of headache days per week
Time Frame: Change from baseline at 6 weeks
Number of days with headache per week without and with using the Allay lamp
Change from baseline at 6 weeks
Change in number of headache days per month
Time Frame: Changes from baseline at weeks 3-6 of using the Allay lamp
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
Change in frequency of experiencing photophobia
Time Frame: Changes from baseline at 6 weeks of using the Allay Lamp.
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.
Change in headache severity
Time Frame: Changes from baseline at 6 weeks of using the Allay lamp
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedanta Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL-20-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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