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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028246
Receipt No. R000032325
Scientific Title Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders
Date of disclosure of the study information 2017/07/14
Last modified on 2018/08/08

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Basic information
Public title Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders
Acronym Autonomic function analysis by using wearable device in FGIDs
Scientific Title Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders
Scientific Title:Acronym Autonomic function analysis by using wearable device in FGIDs
Region
Japan

Condition
Condition Functional dyspepsia, Irritable bowel syndrome
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pathophysiology of functional gastrointestinal disorders by the analysis of the relationship between autonomic nervous system function and gastrointestinal symptoms.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change amounts of autonomic nervous system function during the presence of clinical symptoms
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with functional gastrointestinal disorders who meet criteria for Rome IV
Key exclusion criteria Subjects who have the history of gastrointestinal operation
Subjects who have pacemaker and implantable cardioverter defibrillator
Subjects who is considered as ineligible by the physician
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL 06-6645-3811
Email m2079981@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumio Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL 06-6645-3811
Homepage URL
Email m2079981@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Wellness Open Living Lab. LLC
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 14 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
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We obtain biological information such as autonomic nervous system function by wearing device for 24 hours. We also obtain the information about gastrointestinal symptoms, defecation, and sleep by using the application software on the smartphone.

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032325

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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