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Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices

Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices - Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058109
Enrollment
300
Registered
2025-06-06
Start date
2025-06-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult

Interventions

None listed

Sponsors

TechDoctor, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Males or females aged 18 years or older at the time of obtaining informed consent (2) Individuals who have been previously diagnosed by a physician with a primary headache disorder (such as migraine, tension-type headache, or cluster headache), or who are aware that they currently suffer from a primary headache (3) Individuals who regularly record headache symptoms or related information using a healthcare application (4) Individuals who own a smartphone capable of installing the application for the wearable device, and who can agree to the terms of use for both the wearable device and the application used in this study (5) Individuals who can return the loaned wearable device upon completion of the study (6) Individuals who have provided appropriate written informed consent for participation in this study

Exclusion criteria

Exclusion criteria: (1) Individuals who have been diagnosed with or are aware of having organic (secondary) headaches (2) Individuals with severe psychiatric or neurological disorders (3) Individuals who have been diagnosed with drug or alcohol dependence, either currently or in the past, or who are undergoing treatment for such conditions (including those who, despite the absence of a formal medical diagnosis, are recognized as engaging in habitual excessive drinking or drug abuse) (4) Individuals with infectious diseases or undergoing treatment for other conditions that make health management difficult (5) Individuals who are pregnant or breastfeeding (6) Individuals using devices or medications that may affect heart rate, such as pacemakers or certain drugs (7) Individuals with symptoms such as eczema, allergies, asthma, or sensitive skin that may predispose them to dermatitis from wearable devices (8) Individuals with significantly irregular sleep-wake schedules or who maintain a reversed day-night lifestyle (9) Individuals who self-report prolonged exposure to high levels of stress or who have been diagnosed with stress-related conditions by a medical institution (including those working extreme hours, in irregular shifts, or in professions involving severe mental or physical strain) (10) Individuals or their family members who are employed by companies in competing industries (e.g., pharmaceuticals, cosmetics, health foods) that may be affected by the objectives or outcomes of this study (11) Any other individuals deemed unsuitable for participation in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Correlation between biometric data (e.g., sleep duration, heart rate) and subjective headache intensity

Countries

Japan

Contacts

Public ContactKosaku Kawada

TechDoctor, Inc. Business Development

kawada@technology-doctor.com03-5476-8889

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026