UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008666 |
|---|---|
| Receipt number | R000009144 |
| Scientific Title | Caloric responses to on-step and off-step stimuli in patients with vestibular impairment. |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2023/03/25 11:28:30 |
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Basic information
Public title
Caloric responses to on-step and off-step stimuli in patients with vestibular impairment.
Acronym
Caloric response to step stimulus.
Scientific Title
Caloric responses to on-step and off-step stimuli in patients with vestibular impairment.
Scientific Title:Acronym
Caloric response to step stimulus.
Region
| Japan |
Condition
Condition
Peripheral and central vestibular dysfunction.
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test our novel parameters of evaluating the time course of caloric responses in patients with vestibular dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time courses of the on-step (null-to-supine repositioning) and off-step (supine-to null repositioning) vestibulo-ocular reflexes responses.
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Rapid head movement was combined with continuous caloric irrigation of the external ear, as a substitute for traditional caloric stimulation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit our outpatient clinic and have a battery of vestibular examinations are informed of this clinical study, and subjects who agree to participate are involved in this study.
Key exclusion criteria
No criterion of exclusion were adopted.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tsutsumi |
Organization
Saitama Medical University, Saitama Medical Center
Division name
Department of Otolaryngology
Zip code
Address
Kamoda 1981, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3685
takeoto@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tsutsumi |
Organization
Saitama Medical University, Saitama Medical Center
Division name
Department of Otolaryngology
Zip code
Address
Kamoda 1981, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3685
Homepage URL
takeoto@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009144
