UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015567
Receipt number 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 2022/12/13 11:01:12

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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

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

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 or person

Institute

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

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://doi.org/10.1177/0269215516673208

Number of participants that the trial has enrolled

543

Results

Research Group for Aspiration Pneumonia, National Hospital Organization, Japan. Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial. Clin Rehabil. 2017 Aug;31(8):1049-1056. doi: 10.1177/0269215516673208.

Results date posted

2022 Year 12 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures

To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency.

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

2022 Year 12 Month 13 Day



Link to view the page

Value
https://center6.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