UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044548 |
|---|---|
| Receipt number | R000050347 |
| Scientific Title | Acoustic diversity in perceptual roughness in voice and its vocalization mechanism. |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2024/12/16 19:02:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Acoustic diversity in perceptual roughness in voice and its vocalization mechanism.
Acronym
Perceptual roughness: diversity and mechanism.
Scientific Title
Acoustic diversity in perceptual roughness in voice and its vocalization mechanism.
Scientific Title:Acronym
Perceptual roughness: diversity and mechanism.
Region
| Japan |
Condition
Condition
voice disorder
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classify types of perceptually rough voice by finding the relationship between the various acoustic features and the laryngeal and expiratory airflow findings during vocalization
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between acoustical features and laryngeal high-speed imaging findings
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
High-speed laryngeal imaging, electroglottogram, voice recording, and expiratory flow measurement during vocalization
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Voice disorder patients with a perceptually rough voice
2) Healthy individuals without hoarseness.
Cases of the above whose age is 20 years or older and whose consent to participate in the study have been obtained.
Key exclusion criteria
Patients who meet any of the following conditions will be excluded.
1) Women who are pregnant or may become pregnant
2) Cases of hoarseness due to acute inflammation
3) Patients/healthy people who have difficulty in giving their own consent for research
4) Other patients/healthy people who are judged by the doctor in charge to be inappropriate to participate in this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kiyohito |
| Middle name | |
| Last name | Hosokawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of otorhinolaryngology-head and neck surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3951
khosokawa@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyohito |
| Middle name | |
| Last name | Hosokawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of otorhinolaryngology-head and neck surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3951
Homepage URL
khosokawa@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Academic Clinical Research Center of Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
| 2021 | Year | 06 | Month | 15 | 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
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050347
