UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057622 |
|---|---|
| Receipt number | R000065820 |
| Scientific Title | The Attempt to Measure Vestibular Evoked Myogenic Potentials Using Amplitude-Modulated Sound Stimuli |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/04/22 13:37:11 |
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Basic information
Public title
The Attempt to Measure Vestibular Evoked Myogenic Potentials Using Amplitude-Modulated Sound Stimuli
Acronym
The Attempt to Measure Vestibular Evoked Myogenic Potentials Using Amplitude-Modulated Sound Stimuli
Scientific Title
The Attempt to Measure Vestibular Evoked Myogenic Potentials Using Amplitude-Modulated Sound Stimuli
Scientific Title:Acronym
The Attempt to Measure Vestibular Evoked Myogenic Potentials Using Amplitude-Modulated Sound Stimuli
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cervical vestibular evoked myogenic potential (cVEMP) is a myogenic response recorded in the ipsilateral sternocleidomastoid muscle in response to auditory stimulation. Although it is a response to auditory stimulation, it is a unique reaction originating from the saccule of the vestibular system. We have previously studied the frequency response of cVEMP and reported on its clinical applications. Recently, cVEMP using amplitude-modulated (AM) sound stimulation (AMcVEMP) has been reported, and its clinical application is expected. In this study, we attempted to record AMcVEMP at our facility and considered the significance of AMcVEMP.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The recorded electromyographic data is analyzed approximately one day later to examine the frequency specificity and assess the function of the saccule.
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
| Device,equipment |
Interventions/Control_1
The subjects will be provided with an explanation of the study based on the instruction manual, and their consent will be obtained. The modulated wave will be generated using a frequency counter signal source module. The carrier wave will be set at 500 Hz, and the modulated waves will be set at 17 Hz, 23 Hz, 37 Hz, 113 Hz, and 211 Hz, with 100% modulation. The sound pressure level will be set to 95 dB LA. The sound will be delivered to both ears via insert earphones.
As with the existing cVEMP measurements, the reference electrode will be placed at the mid-point between the sternal head attachment of the sternocleidomastoid muscle and the mastoid process, the ground electrode will be placed on the forehead, and the exploration electrode will be placed at the sternal head attachment of the sternocleidomastoid muscle. To ensure muscle tension in the sternocleidomastoid muscle, the subject will be positioned supine, with their neck rotated away from the side of the sound stimulation. Electromyography will be measured using the Neuro Pack system. The bandpass filter will be set to 20 Hz to 2 kHz. Responses to 1-second stimulation tones will be averaged over 100 trials. Electromyography will also be measured under conditions with no sound stimulation, typical cVEMP, and with only the carrier wave. The total duration of the procedure will be approximately one hour.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Individuals with no prior history of neuro-otological disorders such as vertigo or hearing loss.
2)Individuals who are able to visit the testing site between 2:00 PM and 6:00 PM.
3)Male and female participants aged 20 years or older and under 65 years at the time of consent.
4)Individuals who have received a full explanation of the study, understood it sufficiently, and provided written informed consent of their own free will.
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded from participation in this study:
1)Individuals who have used medications that may affect the test results, such as antivertigo drugs or tranquilizers, within one week prior to the start of the study.
2)Individuals who are prone to motion sickness, such as seasickness or carsickness.
3)Women who are pregnant or may possibly be pregnant.
4)Individuals with a history of cervical conditions that may be aggravated by neck rotation, such as carotid artery stenosis or cervical spondylosis.
5)Women who are currently breastfeeding.
6)Any other individuals deemed unsuitable as study subjects by the principal or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | toru |
| Middle name | |
| Last name | seo |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Otorhinolaryngology
Zip code
216-8511
Address
1197-1 Yazashicho, Asahi-ku, Yokohama, Japan
TEL
0453661111
tseo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Aomi |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Otorhinolaryngology
Zip code
216-8511
Address
1197-1 Yazashicho, Asahi-ku, Yokohama, Japan
TEL
0453661111
Homepage URL
mizuho.okumura@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel
0449778111
soumu@marianna-u.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
| 2025 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065820
