UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052172 |
|---|---|
| Receipt number | R000059542 |
| Scientific Title | Study of an objective evaluation system for persistent perceptual postural vertigo (PPPD) |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/09/11 15:33:57 |
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Basic information
Public title
Study of an objective evaluation system for persistent perceptual postural vertigo (PPPD)
Acronym
Objective evaluation for PPPD
Scientific Title
Study of an objective evaluation system for persistent perceptual postural vertigo (PPPD)
Scientific Title:Acronym
Objective evaluation for PPPD
Region
| Japan |
Condition
Condition
PPPD
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Innovation of objective evaluation for PPPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between symptoms of PPPD and brain blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation of brain blood flow by near infrared spectroscopy in healthy adult subject
Interventions/Control_2
Evaluation of brain blood flow by near infrared spectroscopy in patient with PPPD
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
PPPD patient and healthy adult subject
Key exclusion criteria
(1) People who can not stand upright.
(2) People with psychosis
(3) Pregnant woman
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Shojaku |
Organization
University of Toyama
Division name
Collaborative Research Laboratory of Medical Device Innovation, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama Prefecture
TEL
0764347650
hshojaku@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Shojaku |
Organization
University of Toyama
Division name
Collaborative Research Laboratory of Medical Device Innovation, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama Prefecture
TEL
+81764347650
Homepage URL
hshojaku@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research, Toyama University Hospital
Address
Sugitani, Toyama city, Toyama Prefecture
Tel
0764342281
rinri@adm.u-toyama.ac.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
| 2023 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059542
