MigraineNCT04841083
Narrow Band Green Light and Migraine
A study testing Allay Lamp in people with Migraine and Headache, run by Vedanta Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Allay Lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with headaches or migraines.
Who cannot join
- Not having headaches or migraines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Allay Lamp
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allay LampDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Allay Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of headache days per week
Number of days with headache per week without and with using the Allay lamp
Measured: 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
Measured: 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.
Measured: 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.
Measured: Changes from baseline at 6 weeks of using the Allay lamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start15 Dec 2020
- Primary completion15 Jun 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedanta Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Reed, Vedanta Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841083
- Sponsor's protocol ID
- ALL-20-01
- Status last verified
- Dec 2022
- First submitted
- 1 Apr 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37859647
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency
- ClinicalTrials.gov ID
- NCT04841083
- Acronym / sponsor ID
- ALL-20-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vedanta ResearchUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allay lamp (narrow band green light) | Experimental | Device: Allay LampSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with headaches or migraines.
Key exclusion criteria (1 listed)
- Not having headaches or migraines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allay LampThe 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). | Device | Allay lamp (narrow band green light) |
Primary outcome
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 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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 37859647Lipton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allay Lamp in people with Migraine and Headache, run by Vedanta Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of headache days per week (time frame: Change from baseline at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.