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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040627
Receipt No. 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

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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
Institute National Hospital Organization Tokyo Medical Center
Institute
Department

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
URL(English) https://upload.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


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