UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041172 |
|---|---|
| Receipt number | R000046972 |
| Scientific Title | Evaluation of swallowing functions in sleep in elderly-Exploratory research- |
| Date of disclosure of the study information | 2020/07/21 |
| Last modified on | 2020/07/20 22:05:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of swallowing functions in sleep in elderly-Exploratory research-
Acronym
Evaluation of swallowing functions in sleep
Scientific Title
Evaluation of swallowing functions in sleep in elderly-Exploratory research-
Scientific Title:Acronym
Evaluation of swallowing functions in sleep
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to detect swallowing activity during sleep in healthy people, we investigate relation(correlation) among the waveform obtained from the larynx microphone, surface EMG sensor sheet, and the respirometer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It is confirmed that the respiratory waveform may be stopped when the laryngeal microphone and the sensor sheet react during sleep.
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
We measure swallowing by wearing a surface EMG sensor sheet, laryngeal microphone, respirometer, and Actigraph.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. person who is more than 20 years old.
2. person who can follow oral instructions
3. person with a repetition saliva swallowing test score > 2 and modified water swallowing test score > 3.
4. person who is written informed consent to participate in the study
Key exclusion criteria
1.person who is inability to understand oral instructions.
2.person who embedded pacemaker.
3.person who is dermatitis grade > 1 (also included as radiation)
4.person who is consciousness disorder, insufficient sleep, pneumonia, and poor general condition.
5.Person with high risk of skin symptoms, including contact dermatitis, pruritus, eczema, erythema, subcutaneous bleeding, etc., induced by the sensor sheet.
6.person who have not taken orally.
7.person otherwise judged by the person in charge as unsuitable.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Koyama |
Organization
Shinshu University
Division name
Department of dentistry and oral surgery, School of medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto City, Nagano
TEL
0263-37-2677
kyoshito@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Koyama |
Organization
Shinshu University
Division name
Department of dentistry and oral surgery, School of medicine
Zip code
3908621
Address
3-1-1,Asahi, Matsumoto city, Nagano
TEL
0263-37-2677
Homepage URL
kyoshito@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Ministry of International Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagano Prefecture General Industrial Technology Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu university
Address
3-1-1, Asahi, Matsumoto city,Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | 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 | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046972
