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

JRCT ID: jRCTs042230155

Registered date:19/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atypical Meniere's disease
• Date of first enrollment: 19/02/2024
• Target sample size: 30
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Number of vertigo attacks in 4 weeks based on vertigo symptom calendar
• Secondary Outcome: Lever 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Takakura Hiromasa