UMIN-CTR Clinical Trial

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
Email	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
Email	masashi0324@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034798