UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025221 |
|---|---|
| Receipt number | R000028959 |
| Scientific Title | Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/01/27 07:48:42 |
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Basic information
Public title
Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals
Acronym
Analysis of voice disorder in spasmodic dysphonia
Scientific Title
Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals
Scientific Title:Acronym
Analysis of voice disorder in spasmodic dysphonia
Region
| Japan |
Condition
Condition
spasmodic dysphonia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To specify the acoustic features of voice in spasmodic dysphonia and to investigate the relationship between laryngeal motor disturbance and abnormal voice.
Basic objectives2
Others
Basic objectives -Others
To make simultaneous recording of
acoustic waveform, glottal pulse and laryngeal movement using electro- and photoglottogram and to make comparison with the normal controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acoustic features of voice: pitch perturbation, disturbance of periodicity and voice break.
Key secondary outcomes
Output of electroglottogram and photoglottogram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
voice recording of test sentence reading
Interventions/Control_2
Output of photo- and electroglottogram
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
Expression of full voluntary participation in the research after the full disclosure and understanding of the project plan.
Key exclusion criteria
1. Organic abnormality or paralysis of the larynx.
2. Judgement of unsuitability for inclusion by the chief resercher
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Homma |
Organization
Hokkaido University Hospital
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
7-15, Kita-ku, 0808638, Sapooro, Japan
TEL
011-706-5958
ak-homma@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Nishizawa |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
Address
1757, Kanazawa Tobetsu, 0610293, Ishikari-gun
TEL
0133-23-1211
Homepage URL
nisizawa@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Head and Neck Surgery, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Organization
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
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
北海道大学病院（北海道）
北海道医療大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
1
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
| 2016 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 26 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028959
