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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025221
Receipt No. 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 2016/12/12

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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
Email 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
Email nisizawa@hoku-iryo-u.ac.jp

Sponsor
Institute Department of Otolaryngology, Head and Neck Surgery, Hokkaido University Hospital
Institute
Department

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
Email

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
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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
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
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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