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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
182
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).
Vendata Research
Chapel Hill, North Carolina, United States
Change in number of headache days per week
Number of days with headache per week without and with using the Allay lamp
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Changes from baseline at 6 weeks of using the Allay lamp
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