UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Title of the study (Brief title)	Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Region	Japan

Condition
Condition	Meniere's disease, delayed endolymphatic hydrops
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An attempt was made to examine the efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Monthly-averaged frequency of vertigo attack
Key secondary outcomes	Vestibular and auditory functions

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The 3 min-application of positive-negative pressure to the external auditory canal with the middle ear pressure therapy device t.i.d. for 16 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Adult (20-80 y/o) patients with intractable definite Meniere's disease and delayed endolymphatic hydrops
Key exclusion criteria	1) Patients with otitis media. 2) Patients with cardiac pacemaker and implantable cardiac defibrillator. 3) Patients with diseases of the auricle and external auditory canal. 4) Patients who was excluded by investigators.
Target sample size	180

Research contact person
Name of lead principal investigator	Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Email	takeda@tokushima-u.ac.jp

Public contact
Name of contact person	Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Homepage URL
Email	takeda@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	Grant-in-Aid from the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2018 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020518