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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030573
Receipt No. R000034905
Scientific Title Effect of postural change on heart rate variability: quantitative assessment of autonomic failure
Date of disclosure of the study information 2017/12/26
Last modified on 2019/06/28

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Basic information
Public title Effect of postural change on heart rate variability: quantitative assessment of autonomic failure
Acronym Effect of postural change on heart rate variability
Scientific Title Effect of postural change on heart rate variability: quantitative assessment of autonomic failure
Scientific Title:Acronym Effect of postural change on heart rate variability
Region
Japan

Condition
Condition Healthy control,patients with rapid eye movement sleep behavior disorder
Classification by specialty
Neurology Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To obtain measurement method to quantitative assessment of autonomic failure by using heart rate variability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Association between changes of blood pressure and heart rate variability from supine to standing position.
Key secondary outcomes Height, weight, pulse, past history, family history, drinking history, smoking history, medicine information, Barthel Index score, MMSE score, RBDSQ - J score, x, y, z axis acceleration and angular acceleration

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
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) inclusion criteria of healthy control
a) those who participate voluntarily
b) have not been diagnosed with autonomic failure

(2) inclusion criteria of patients
a) those who visit department of psychiatric or sleep center of Shiga University of Medical Science
b) diagnosed with rapid eye movement sleep behavior disorder according to ICSD-2 or 3
Key exclusion criteria those who considered to be inappropriate by doctors
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Matsuo
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code 520-2192
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL (+81)-77-548-2291
Email mazzuo@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Matsuo
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code 520-2192
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL (+81)-77-548-2291
Homepage URL https://www.shiga-med.ac.jp
Email mazzuo@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Shiga University of Medical Science Hospital Clinical Research and Medical Innovation Center
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
Tel (+81)-77-548-3619
Email cramwin@belle.shiga-med.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 滋賀医科大学(滋賀県)、京都大学(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 26 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 24 Day
Date of IRB
2019 Year 05 Month 23 Day
Anticipated trial start date
2017 Year 12 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information Results of research will be presented at academic conference or published in paper

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034905

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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