A Study of Wearable Devices to Predict Migraines

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

eHealth Application

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years and older (no upper age limit defined) 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: Chronic daily headache with no periods of headache freedom. ≥ 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.

Sites / Locations

Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Custom Phone eHealth Application

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.

Percentage accuracy of fit with AUC of the ROC curve for factors from data collected from custom phone app integrated with smart devices to track headache frequency and severity.

Secondary Outcome Measures

Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.

Percentage accuracy of fit with AUC of the ROC curve for data from custom phone app integrated with smart devices to forecast periods of increased headache likelihood.

Correlation coefficients of wearable sensor data to headache frequency and severity.

Correlation of novel physiological clinical outcome data (e.g., time in bed, average sleep time, stand time, exercise time, move time, walking distance, running distance, estimated six-minute walk, steps per day, heart rate, heart rate variability) to monthly headache days, moderate to severe monthly headache days, analgesic use, MIDAS, and HIT-6.

uMARS app quality mean score

Quality of the custom phone app integrated with smart watches as assessed by the validated uMARS.

Full Information

NCT ID

NCT05755945

First Posted

February 23, 2023

Last Updated

April 19, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05755945

Brief Title

A Study of Wearable Devices to Predict Migraines

Official Title

A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Predict and Track Clinical Outcomes in Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 24, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this research is to determine if data from smart devices, including heart rate and movement during sleep and wake times, will be able to track headaches and predict recurrence and exacerbations (make worse). This use of this information may in the future allow patients earlier and more effective treatments if these devices can help predict when the headaches may occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Custom Phone eHealth Application

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

eHealth Application

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.

Description

Percentage accuracy of fit with AUC of the ROC curve for factors from data collected from custom phone app integrated with smart devices to track headache frequency and severity.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.

Description

Percentage accuracy of fit with AUC of the ROC curve for data from custom phone app integrated with smart devices to forecast periods of increased headache likelihood.

Time Frame

6 months

Title

Correlation coefficients of wearable sensor data to headache frequency and severity.

Description

Correlation of novel physiological clinical outcome data (e.g., time in bed, average sleep time, stand time, exercise time, move time, walking distance, running distance, estimated six-minute walk, steps per day, heart rate, heart rate variability) to monthly headache days, moderate to severe monthly headache days, analgesic use, MIDAS, and HIT-6.

Time Frame

6 months

Title

uMARS app quality mean score

Description

Quality of the custom phone app integrated with smart watches as assessed by the validated uMARS.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age 18 years and older (no upper age limit defined) 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: Chronic daily headache with no periods of headache freedom. ≥ 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naraya Kissoon, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Minnesota

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial