Headache, Migraine
Conditions
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.
Interventions
DEVICEAllay 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).
Sponsors
Vedanta Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with headaches or migraines.
Exclusion criteria
* Not having headaches or migraines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of headache days per week | Change from baseline at 6 weeks | Number of days with headache per week without and with using the Allay lamp |
| Change in number of headache days per month | 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 |
| Change in frequency of experiencing photophobia | 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. |
| Change in headache severity | 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. |
Countries
United States
Outcome results
None listed