UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040627
Receipt number R000046367
Scientific Title Measurement of the standard value of the elderly to determine the clinical significance of blood substance P level as an objective evaluation index for the prediction of aspiration due to glottal insufficiency
Date of disclosure of the study information 2020/06/11
Last modified on 2021/06/03 10:39:06

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Basic information

Public title

Measurement of the standard value of the elderly to determine the clinical significance of blood substance P level as an objective evaluation index for the prediction of aspiration due to glottal insufficiency

Acronym

Average value of substance P in the elderly

Scientific Title

Measurement of the standard value of the elderly to determine the clinical significance of blood substance P level as an objective evaluation index for the prediction of aspiration due to glottal insufficiency

Scientific Title:Acronym

Average value of substance P in the elderly

Region

Japan


Condition

Condition

healthy elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the average value of blood substance P in the elderly.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

plasma Substance P value in healthy elderly

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Venous blood sample

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Men and women over the age of 65
2. Those who come to our hospital as an otolaryngology outpatient with normal phonation and swallowing
3. Those who do not have glottal insufficiency during phonation due to vocal cord atrophy on laryngoscopy
4. Those who do not have paralysis in the vocal cords on either side of the larynx and have no other organic functional disorder or disease
5. Those with a maximum phonation time (MPT) of 15 seconds or more
6. Paticipants who match above and agree to cooperate the research

Key exclusion criteria

1. Those who do not understand Japanese
2. Those who are targeted for treatment in the ENT department, those who are taking ACE inhibitors for other treatments
3. MPT less than 15 seconds
4. Persons admitted by each institution doctor as an indication for vocal self-training

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name Tsunoda
Last name Tsunoda

Organization

National Hospital Organization Tokyo Medical Center

Division name

Clinical Research Center/Otolaryngology

Zip code

152-8902

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo,Japan

TEL

0334110111

Email

tsunodakoichi@kankakuki.go.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Tsunoda

Organization

National Hospital Organization National Tokyo Medical Center

Division name

Artificial Organs and Medical Creations/Otolaryngology

Zip code

152-8902

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo,Japan

TEL

0334110111

Homepage URL


Email

tsunodakoichi@kankakuki.go.jp


Sponsor or person

Institute

National Hospital Organization Tokyo Medical Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Tokyo Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Tokyo Medical Center Ethics Committee

Address

2-5-1 Higashigaoka Meguro-ku, Tokyo, Japan

Tel

03-3411-0111

Email

oosaka.shunji.gv@mail.hosp.go.jp


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

国立病院機構東京医療センター、国立病院機構相模原病院、国立病院機構神戸医療センター


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 11 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

Enrolling by invitation

Date of protocol fixation

2020 Year 05 Month 11 Day

Date of IRB

2020 Year 05 Month 11 Day

Anticipated trial start date

2020 Year 06 Month 11 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 02 Day

Last modified on

2021 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name