UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041164 |
|---|---|
| Receipt number | R000044686 |
| Scientific Title | Effect of local positive pressure therapy for inner ear vertigenous disease |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2022/07/22 09:52:30 |
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Basic information
Public title
Effect of local positive pressure therapy for Meniere disease and delayed endolymphatic hydrops.
Acronym
Effect of local positive pressure therapy
Scientific Title
Effect of local positive pressure therapy for inner ear vertigenous disease
Scientific Title:Acronym
Effect of local positive pressure therapy
Region
| Japan |
Condition
Condition
meniere disease
delayed endolymphatic hydrops
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
reduction of frequency in vertigo attacks and volume of endolymphatic hydrops
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of vertigo attacks
volume of endolymphatic hydrops
Key secondary outcomes
auditory and vestibular function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
medications, six months to one year
Interventions/Control_2
middle ear pressure or surgery, six months to one year
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
recurrent vertigeneous patients, such as Meniere disease and so on.
Key exclusion criteria
perforation of ear drum
patients woth severe renal disease and asthma.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Munehisa |
| Middle name | |
| Last name | Fukushima |
Organization
Kansai Rosai Hospital
Division name
Otolaryngology and Head and Neck Surgery
Zip code
660-8511
Address
3-1-69 Inabaso, Amagasaki, Hyogo
TEL
06-6416-1221
mfukushima@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | Munehisa |
| Middle name | |
| Last name | Fukushima |
Organization
Kansai Rosai Hospital
Division name
660-8511
Zip code
660-8511
Address
+81-6-6416-1221
TEL
06-6416-1221
Homepage URL
mfukushima@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Rosai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Rosai Hospital
Address
3-1-69 Inabaso, Amagasaki, Hyogo
Tel
06-6416-1221
mfukushima@kansaih.johas.go.jp
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
| 2020 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044686
