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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015567
Receipt No. R000018088
Scientific Title Research on the therapeutic Interventional effect of Self-controlled vocal exercise : SCVE) for patients with dysphonia caused by physiological vocal cord atrophy due to aging.
Date of disclosure of the study information 2014/11/01
Last modified on 2016/06/30

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Basic information
Public title Research on the therapeutic
Interventional effect of
Self-controlled vocal exercise : SCVE)
for patients with dysphonia caused by physiological vocal cord atrophy due to aging.
Acronym Randomized controlled trial in multiple centers
on the interventional therapy of
Self-controlled vocal exercise : SCVE) for aging vocal cord atrophy.
Scientific Title Research on the therapeutic
Interventional effect of
Self-controlled vocal exercise : SCVE)
for patients with dysphonia caused by physiological vocal cord atrophy due to aging.
Scientific Title:Acronym Randomized controlled trial in multiple centers
on the interventional therapy of
Self-controlled vocal exercise : SCVE) for aging vocal cord atrophy.
Region
Japan

Condition
Condition Sulcus or Atrophy of vocal cords
Classification by specialty
Medicine in general Geriatrics Oto-rhino-laryngology
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effect of
Self-controlled vocal exercise : SCVE)
for dysphonia, and aspiration
pneumonia caused by vocal cord atrophy
due to aging
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence rate of pneumonia
Maximum phonation time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Self-controlled vocal exercise : SCVE)
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
60 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria 1)60 years old and over
2) experiencing hoarseness caused by glottal incompetence;
3) diagnosis of atrophy of the vocal cords or sulcus vocalis as confirmed in laryngeal endoscopic examination.
Key exclusion criteria 1) patient preference for surgical treatment;
2) inability to perform the SCVE for any reason;
3) acute inflammation, polyps, tumors, granulomas, nodules, or paralysis of the vocal cords.
Target sample size 600

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Koichi Tsunoda
Organization National Hospital Organization Tokyo medical center National Institute of Sensory Organs, Tokyo, Japan
Division name Department of Artificial Organs and Medical Device Creation
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo,zip 152-8902
TEL 03-3411-0111
Email tsunodakoichi@kankakuki.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Koichi Tsunoda
Organization National Hospital Organization Tokyo medical center National Institute of Sensory Organs
Division name Department of Artificial Organs and Medical Device Creation
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo,zip 152-8902
TEL 03-3411-0111
Homepage URL
Email tsunodakoichi@kankakuki.go.jp

Sponsor
Institute National Hospital Organization Tokyo medical center National Institute of Sensory Organs, Tokyo, Japan
Institute
Department

Funding Source
Organization National Hospital Organization Network Joint Research Fund.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 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 Completed
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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
2014 Year 10 Month 30 Day
Last modified on
2016 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018088

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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