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
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
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
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
