UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027661 |
|---|---|
| Receipt number | R000027789 |
| Scientific Title | Sutudy of the Swallowing Sounds Recorded through the Ear |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2025/01/23 14:45:38 |
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Basic information
Public title
Sutudy of the Swallowing Sounds Recorded through the Ear
Acronym
Swallowing Sounds Recorded through the Ear
Scientific Title
Sutudy of the Swallowing Sounds Recorded through the Ear
Scientific Title:Acronym
Swallowing Sounds Recorded through the Ear
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether intra-aural swallowing sounds can be clinically applied as a temporal indicator of swallowing function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time of intra-aural swallowing sounds
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.There is a difficulty swallowing feeling
2.20 years of age or older men and women
3.Written consent was obtained
4.Otolaryngologist has determined that there is no ear disease
Key exclusion criteria
1.Minor
2.Have inserted a tracheotomy cannula
3.Have inserted a stomach tube
4.Suspected inflammatory condition
5.It is inhaled continuously oxygen
During pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1Maidashi Higashi-ku Fukuoka
TEL
092-642-5668
styama@qent.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1Maidashi Higashi-ku Fukuoka
TEL
092-642-5668
Homepage URL
styama@qent.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University.
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University.
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 Japan
Tel
092-642-5668
styama@qent.med.kyushu-u.ac.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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027789
