UMIN-CTR Clinical Trial

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
Email	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
Email	kyoshito@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046972