UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058109 |
|---|---|
| Receipt number | R000066412 |
| Scientific Title | Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/06 17:45:46 |
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Basic information
Public title
Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices
Acronym
Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices
Scientific Title
Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices
Scientific Title:Acronym
Evaluation of Quality of Life in Patients with Primary Headache Using Subjective Symptom Records and Biometric Data from Wearable Devices
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to comprehensively evaluate the relationship between quality of life (QOL) and headache symptoms in adults with primary headache, by combining subjective symptom records via a smartphone application and biometric data collected through a wrist-worn wearable device.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to comprehensively evaluate the relationship between quality of life (QOL) and headache symptoms in adults with primary headache, by combining subjective symptom records via a smartphone application and biometric data collected through a wrist-worn wearable device.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between biometric data (e.g., sleep duration, heart rate) and subjective headache intensity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazumichi |
| Middle name | |
| Last name | Minato |
Organization
TechDoctor, Inc.
Division name
Board Member
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
minato@technology-doctor.com
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Kawada |
Organization
TechDoctor, Inc.
Division name
Business Development
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
Homepage URL
kawada@technology-doctor.com
Sponsor or person
Institute
TechDoctor, Inc.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
070-6995-0047
hiroyuki-t.sr@cmicgroup.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this study is to comprehensively evaluate the relationship between quality of life (QOL) and headache symptoms in adults with primary headache, by combining subjective symptom records via a smartphone application and biometric data collected through a wrist-worn wearable device.
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066412
