NIPH Clinical Trials Search

JRCT ID: jRCTs042230155

Registered date:19/02/2024

Middle ear pressuretreatment by EFET01 in patients with atypical Meniere's disease

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAtypical Meniere's disease
Date of first enrollment19/02/2024
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Patient receives middle ear pressure treatment (MEPT) by EFET01 at home for 3 minutes per sesssion, twice a day. Vertigo symptom calendar is kept to record the level of vertigo, subjective distress and activity level. Patient is seen 4 weeks before the start of MEPT, and 1,2,3, and 4 months after the start of MEPT in order to evaluate subjective symptom and objective examination.


Primary OutcomeNumber of vertigo attacks in 4 weeks based on vertigo symptom calendar
Secondary OutcomeLever of vertigo attacks, subjective distress and activity level in 4 weeks based on vertigo symptom calendar

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
Include criteria1) Patient aged between 18 and 80 years old 2) Untreated patient who was diagnosed as atypical Meniere's disease based on the Clinical practice guidelines for Meniere's disease and delayed endolymphatic hydrops 2020 3) Patient who understands treatment method and procedure and is able to agree in writing of his own free will 4) Patinet who can use EFET01 correctly at home 5) Patient that conservative treatment is invalid
Exclude criteria1) Patient using life support dispute 2) Patient using cardiac pacemarker and implantale defibrillator 3) Patient who has disase or injury in auricle and/or external auditory canal 4) Patient with tympanic membrane perforation 5) Patient unable to comply treatment method and procedure 6) Patient who was evaluated as ineligible person by doctor in charge

Related Information


Public contact
Name Hiromasa Takakura
Address 2630 Sugitani, Toyama Toyama Japan 930-0194
Telephone +81-76-434-7368
Affiliation University of Toyama
Scientific contact
Name Hiromasa Takakura
Address 2630 Sugitani, Toyama city, Toyama prefecture Toyama Japan 930-0194
Telephone +81-76-434-7650
Affiliation Toyama University Hospital