UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052506 |
|---|---|
| Receipt number | R000059906 |
| Scientific Title | Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation. |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/04/16 12:28:02 |
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Basic information
Public title
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation.
Acronym
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation.
Scientific Title
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation.
Scientific Title:Acronym
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation.
Region
| Japan |
Condition
Condition
vestibular disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the nystagmus observation abilities of a new portable Fresnel magnifying loupe and conventional Frenzel goggles or infrared video glasses in patients with vestibular disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number and slow-phase velocity of nystagmus induced by head shaking test during observation with the new loupes, conventional Frenzel goggles and infrared video nystagmus goggles.
Key secondary outcomes
Slow phase velocity of nystagmus while observing spontaneous nystagmus with the new loupes, Frenzel goggles, and infrared video nystagmus goggles.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who understand the content of the study and have given their written consent to participate in the study.
Key exclusion criteria
Those who are considered inappropriate by the principal investigator or co-investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Ear Institute Clinic
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama, Japan
TEL
+81-48-797-3341
r.tsunoda@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Ear Institute Clinic
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama, Japan
TEL
+81-48-797-3341
Homepage URL
r.tsunoda@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Reiko Tsunoda
Funding Source
Organization
Mejiro University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Mejiro University
Address
Shomu, 320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
Tel
+81-48-797-2115
univsyomu@mejiro.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
目白大学耳科学研究所クリニック(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 17 | 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
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure the number and slow phase velocity of nystagmus while observing head shaking nystagmus with a new type of loupe, Frenzel goggles, and infrared video goggles.
To measure the slow phase velocity while observing spontaneous nystagmus with a new loupe, Frenzel goggles, and infrared video goggles.
Slow phase velocity is measured from ENG recordings.
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059906
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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