Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
20 participants
INTERVENTIONAL
2023-02-24
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Custom Phone eHealth Application
Subjects diagnosed with migraine headaches and have had a positive response to prevention treatments for migraine, will wear an Apple Watch whenever possible (including during sleep) and complete application questionnaires on the eHealth application daily.
eHealth Application
Custom phone application that integrates data from smart watch. Subjects will complete daily "To-Do-Lists" where data will be collected on if they had a headache in the past 24 hours, severity of headache, and any analgesics used to treat the headache.
Interventions
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eHealth Application
Custom phone application that integrates data from smart watch. Subjects will complete daily "To-Do-Lists" where data will be collected on if they had a headache in the past 24 hours, severity of headache, and any analgesics used to treat the headache.
Eligibility Criteria
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Inclusion Criteria
* History of chronic migraine as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
* Response to current preventative therapy with ≥ 50% improvement in the frequency of headache days when compared to baseline
* 4 to 14 average number of total headache days per month during peak efficacy of preventative therapy
* Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
* Patient agrees to maintain a daily electronic headache diary.
* Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. - Subjects owns an iPhone with iOS 16 or later operating system installed on iPhone. Apple watch series 8 with watch OS6 or later will be provided by the study.
Exclusion Criteria
* ≥ 15 average number of headaches days per month during peak efficacy of preventative treatment.
* Medication overuse headache as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
* Daily opioid use for \> 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Narayan R. Kissoon
Principal Investigator
Principal Investigators
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Naraya Kissoon, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-009944
Identifier Type: -
Identifier Source: org_study_id
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