UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022413 |
|---|---|
| Receipt number | R000025830 |
| Scientific Title | Evaluation of the effect of sound stimulation on physiological functions |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2023/04/19 17:26:06 |
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Basic information
Public title
Evaluation of the effect of sound stimulation on motion sickness
Acronym
Evaluation of sound stimulation
Scientific Title
Evaluation of the effect of sound stimulation on physiological functions
Scientific Title:Acronym
Evaluation of sound stimulation
Region
| Japan |
Condition
Condition
Motion sickness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at evaluating the frequency-dependent effects of sound on motion sickness in humans.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome Name: inner ear functions
Metric/method of measurement: Posturography, Vestibular evoked myogenic potential (VEMP), Distortion product otoacoustic emissions (DPOAEs), Pure-tone audiometry (PTA)
Timepoint: before and after interventions
Key secondary outcomes
Outcome Name: physiological functions and subjective symptoms
Metric/method of measurement: electrocardiogram, heart rate variability and questionnaires
Timepoint: before and after interventions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Sound stimulation
Interventions/Control_2
Sound stimulation, linear shaking
Interventions/Control_3
Sound stimulation, driving simulator
Interventions/Control_4
Sound stimulation, car
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
Healthy subjects without hearing and vestibular dysfunction such as vertigo and tinnitus are included in this study.
Key exclusion criteria
Subjects below 20 years old are excluded. Subjects who are older than 20 years old but do not have sufficient judgment or conscious mind, or are worried about the experiments are also excluded. In addition, subjects with contraindications to the medical devices used in this study are also excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Occupational and Environmental Health
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2124
katomasa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Ohgami |
Organization
Nagoya University Graduate School of Medicine
Division name
Occupational and Environmental Health
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2124
Homepage URL
eisei1@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Ethics Committee of Nagoya University School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
iga-shinsa@adm.nagoya-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
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
116
Results
Motion sickness caused by linear shaking, driving simulator and a car decreased the vestibular function of participants.
Sound stimulation improved the decreased vestibular function caused by shaking.
Results date posted
| 2023 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Intervention 1: Sound stimulation
15 participants, 14 male and 1 female, Age (Mean): 43.13 years old.
Intervention 2: Sound stimulation, linear shaking
44 participants, 9 male and 35 female, Age (Mean): 28.30 years old.
Intervention 3: Sound stimulation, driving simulator
53 participants, 15 male and 38 female, Age (Mean): 25.23 years old.
Intervention 4: Sound stimulation, car
12 participants, 7 male and 5 female, Age (Mean): 36.25 years old.
Participant flow
Intervention 1: Sound stimulation
15 participants, Research period: 2016.10-2022.12
Intervention 2: Sound stimulation, linear shaking
44 participants, Research period: 2019.10-2021.02
Intervention 3: Sound stimulation, driving simulator
53 participants, Research period: 2020.02-2020.07
Intervention 4: Sound stimulation, car
12 participants, Research period: 2021.09-2021.11
Adverse events
No adverse events.
Outcome measures
Intervention 1: Sound stimulation
Results 1: Sound stimulation has no adverse effects on participants' hearing function.
Intervention 2: Sound stimulation, linear shaking
Results 2: Linear shaking decreased the vestibular function of participants. Sound stimulation improved the decreased vestibular function caused by the linear shaking.
Intervention 3: Sound stimulation, driving simulator
Results 3: Driving simulator shaking decreased the vestibular function of participants. Sound stimulation improved the decreased vestibular function caused by the driving simulator.
Intervention 4: Sound stimulation, car
Results 4: The vestibular function of participants with motion sickness caused by a car was decreased. Sound stimulation improved the decreased vestibular function caused by a car.
Plan to share IPD
Yes, IPD may be provided upon request.
IPD sharing Plan description
Data obtained through this study may be provided to qualified researchers with an academic interest in this study. Data shared will be coded, with no protected health information (PHI) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025830
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