UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030487 |
|---|---|
| Receipt number | R000034798 |
| Scientific Title | Study of cardiac parasympathetic dysfunction in Parkinson's disease by using wearable devices |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/06/22 13:47:31 |
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Basic information
Public title
Study of cardiac parasympathetic dysfunction in Parkinson's disease by using wearable devices
Acronym
Study of cardiac parasympathetic dysfunction in Parkinson's disease by using wearable devices
Scientific Title
Study of cardiac parasympathetic dysfunction in Parkinson's disease by using wearable devices
Scientific Title:Acronym
Study of cardiac parasympathetic dysfunction in Parkinson's disease by using wearable devices
Region
| Japan |
Condition
Condition
Parkinson's syndrome, Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore a early diagnosis marker for Parkinson's disease by using wearable devices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability analysis by using wearable devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
wearable devices
Interventions/Control_2
wearable devices
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease
Parkinson's syndrome
Key exclusion criteria
Diabetes
Heart disease
Autonomic neuropathy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahisa |
| Middle name | |
| Last name | Katsuno |
Organization
Nagoya university graduate school of medicine
Division name
neurology
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2391
ka2no@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya university graduate school of medicine
Division name
neurology
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2391
Homepage URL
masashi0324@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education culture,sports,science and technology-Japan
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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-741-2111
ethics@med.nagoya-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
| 2018 | Year | 04 | 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
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study we analyze heart rate variability by using wearable devices.
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034798
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
