Retrospective Performance Evaluation of a Headache Diagnostic Program for Supporting the Diagnosis of Primary Headache

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1032250289

Enrollment

327

Registered

2025-08-13

Start date

2025-08-13

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

headache disorder

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: The data are registered in the observational study (jRCT1030240662).

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Based on the confirmed diagnosis by a headache specialist as the reference standard, the lower bound of the 95% confidence interval for the sensitivity of this product in both Class 1 and Class 2 surpasses the pre-defined performance target.	—

Secondary

Measure	Time frame
1. Overall accuracy and area under the curve (AUC) of the product across all classes, using the confirmed diagnosis by a headache specialist as the reference standard. 2. Specificity, accuracy, and AUC of the product for Class 1 and Class 2, using the confirmed diagnosis by a headache specialist as the reference standard. 3. Sensitivity, specificity, accuracy, and AUC of the product for Class 3 and Class X, using the confirmed diagnosis by a headache specialist as the reference standard. 4. Sensitivity, specificity, and accuracy of the product for Class 3+X (Class 3 or Class X), using the confirmed diagnosis by a headache specialist as the reference standard.	—

Measure

Time frame

1. Overall accuracy and area under the curve (AUC) of the product across all classes, using the confirmed diagnosis by a headache specialist as the reference standard. 2. Specificity, accuracy, and AUC of the product for Class 1 and Class 2, using the confirmed diagnosis by a headache specialist as the reference standard. 3. Sensitivity, specificity, accuracy, and AUC of the product for Class 3 and Class X, using the confirmed diagnosis by a headache specialist as the reference standard. 4. Sensitivity, specificity, and accuracy of the product for Class 3+X (Class 3 or Class X), using the confirmed diagnosis by a headache specialist as the reference standard.

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Contacts

Public ContactYuya Karino

Hedgehog MedTech, Inc.

yuya.karino@h-medtech.com+81-80-5430-2115

Outcome results