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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2021/07/23 R.3病院機能向上(福嶋).docx

Research case data specifications
Registered date File name
2021/07/23 症例報告書.xls

Research case data
Registered date File name