Narrow Band Green Light and Migraine

NCT04841083 | Completed

• 1 other identifier: ALL-20-01
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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.

• 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

Study Arms (1)

Allay lamp (narrow band green light)

EXPERIMENTAL

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

Interventions

Allay Lamp DEVICE

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).

Allay lamp (narrow band green light)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with headaches or migraines.

You may not qualify if:

• Not having headaches or migraines

Sponsors & Collaborators

• Vedanta Research: lead

Study Sites (1)

Vendata Research

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (1)

• Lipton RB, Melo-Carrillo A, Severs M, Reed M, Ashina S, Houle T, Burstein R. Narrow band green light effects on headache, photophobia, sleep, and anxiety among migraine patients: an open-label study conducted online using daily headache diary. Front Neurol. 2023 Oct 4;14:1282236. doi: 10.3389/fneur.2023.1282236. eCollection 2023.

  PMID: 37859647 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Director

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 12, 2021
• Study Start: December 15, 2020
• Primary Completion: June 15, 2022
• Study Completion: December 5, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

US (1)