CHS CHS
Conditions
Interventions
Treatment will be performed using a Class II controlled medical device (ESPURGE or PICORINA modified version, Clark VN, manufactured by Ito Chotampa (a machine based on PICORINA that has been modified
Sponsors
Satoshi Konnno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Among the research participants, those who (2) meet all the selection criteria and (3) do not fall under any of the exclusion criteria will be considered eligible. (1) Research Participants Patients with CHS who are receiving outpatient or inpatient treatment at Hokkaido University Hospital (Department of Respiratory Medicine), Kinki University Hospital, or Shonan Kamakura General Hospital between the date of approval and January 31, 2028. (2) Selection Criteria Patients who meet all of the following criteria will be included: Those aged 18 or older at the time of obtaining consent Those diagnosed with CHS by a physician Those who, after receiving sufficient explanation regarding participation in this study, were able to actively understand the informed consent document and provided written consent of their own free will.
Exclusion criteria
Exclusion criteria: (3) Exclusion Criteria Patients who meet any of the following criteria will be excluded from the study. Individuals with a history of progressive brain lesions Individuals receiving vagus nerve stimulation therapy Individuals with a history of severe cardiovascular disease Individuals with a history of glycerin hypersensitivity Pregnant or breastfeeding individuals Individuals with skin hypersensitivity and a history of skin reactions due to metals, etc. Individuals who have difficulty taking the medication orally Individuals using a cardiac pacemaker or implantable cardioverter-defibrillator Other individuals deemed unsuitable as research subjects by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cough symptoms before and after treatment (at 28 weeks), as assessed by VAS, following low-frequency electrical stimulation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Presence or absence of adverse events during low-frequency therapy Changes in QOL (Japanese version LCQ, EQ-5D-5L), cough severity, and number of triggering factors before and after low-frequency therapy (based on the Japanese version of the cough hypersensitivity questionnaire and numerical rating scales) Changes in disease activity in LCQ and QEESI before and after low-frequency therapy Presence or absence of exacerbating attacks during low-frequency therapy Localization of immune cells, expression positivity and intensity of molecules induced by inflammation, presence or absence of disease-related gene variants, and association with the disease state before and after low-frequency therapy. Correlation between the state of inflammation and the expression status of clinicopathological factors and other analyzed molecules. | — |
Contacts
Public ContactYuichi Kojima
Hokkaido University Hospital
Outcome results
None listed