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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04841083
Other study ID # ALL-20-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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