Patients with hot flashes Hot flush
Conditions
Interventions
First, enroll three healthy subjects to confirm safety. After completing static magnetic field stimulation with Magnet Device 1, safety will be confirmed, focusing primarily on the occurrence of adver
Magnetic Stimulation Device
Sponsors
Fushimi Atsushi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Healthy individuals 1) Women aged 40 to 60 years at the time of consent acquisition, currently healthy and not undergoing treatment for any disease 2) Individuals who have read the recruitment notice, understood the purpose of this study, and voluntarily offered to participate 3) Individuals for whom written consent to participate in the study has been obtained 4) Individuals who have not participated in any other clinical trial involving intervention within the past three months 5) Individuals capable of performing the study procedures (e.g., attending appointments, completing diaries, wearing devices) and able to manage their own care and maintain communication. Patients with hot flushes 1) Women experiencing hot flush symptoms at least five times per week. 2) Individuals aged 40 to 60 years at the time of consent acquisition. 3) Cancer patients must be free of metastasis or recurrence and in stable general condition (guideline: American Society of Anesthesiologists physical status score of 2 or below). 4) Individuals who are either untreated for menopausal symptoms such as hot flushes or who are taking herbal medicine but have not experienced symptom improvement (no treatment or supplements for hot flushes for at least one month prior to trial participation) 5) Individuals who have provided written consent to participate in the study
Exclusion criteria
Exclusion criteria: Healthy individuals 1) Those undergoing treatment for any disease at the time of consent acquisition 2) Those with malignant tumours or under observation due to a history thereof 3) Those with obvious cardiovascular disorders such as heart disease 4) Those with implanted medical devices or metallic objects susceptible to magnetic fields (pacemakers, defibrillators, artificial joints, stents, cerebral aneurysm clips) 5) Individuals with blood coagulation disorders 6) Individuals with severe peripheral circulatory disorders or sensory impairment due to conditions such as diabetes 7) Individuals with infection, inflammation, or wounds on the skin at the intended application site (neck to clavicle area) 8) Individuals with a fever of 38 degrees or higher at the time of consent acquisition 9) Individuals in the early stages of pregnancy (unstable period) or immediately postpartum 10) Any other individual deemed unsuitable for participation in this study by the principal investigator or co-investigator Patients with hot flush symptoms 1) Individuals without cancer recurrence or metastasis (including those with recurrence,progression or undergoing treatment) 2) Individuals with blood coagulation disorders, or those at high risk of bleeding due to anticoagulant therapy, etc. 3) Individuals with implanted magnetic devices or medical devices/metals susceptible to magnetic fields ( pacemakers, ICDs, stents, cerebral aneurysm clips, artificial joints) 4) Individuals with significant cardiovascular disorders (including history of syncope, severe arrhythmia, severe hypertension, etc.) 5) Individuals with infection, inflammation, or wounds on the skin at the intended application site (neck to clavicle area) 6) Individuals in the first trimester (unstable period) of pregnancy or immediately postpartum 7) Individuals who have used treatment or supplements for hot flushes within the past month (including herbal medicine, HRT, antidepressants) 8) Individuals deemed unable to comply with study procedures or undergo assessments due to cognitive impairment, severe psychiatric disorders, etc. 9) Other individuals deemed unsuitable by the principal investigator or coinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence, types, and severity of adverse events (AEs) occurring during static magnetic field stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study investigates the effects of static magnetic field stimulation on hot flush symptoms and sleep-related indicators, confirming the presence or absence of physiological changes due to sympathetic inhibition. | — |
Contacts
Public ContactAtsushi Fushimi
The Jikei University Hospital
Outcome results
None listed