UMIN-CTR Clinical Trial

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