UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030573 |
|---|---|
| Receipt number | 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 | 2023/07/04 15:06:20 |
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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 | Yukiyoshi |
| Middle name | |
| Last name | Sumi |
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
ysumi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiyoshi |
| Middle name | |
| Last name | Sumi |
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
ysumi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
https://www.frontiersin.org/articles/10.3389/fneur.2020.567984/full
Publication of results
Partially published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fneur.2020.567984/full
Number of participants that the trial has enrolled
89
Results
Orthostatic hypotension (OH) caused by autonomic dysfunction is a common symptom in idiopathic rapid eye movement sleep behavior disorder (iRBD). Although previous studies have reported that changes in heart rate variability (HRV) are associated with autonomic dysfunction, no study has investigated the relationship between HRV before standing and the occurrence of OH. Our study showed the possibility that short-term HRV indices in the supine position would predict subsequent OH.
Results date posted
| 2021 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 23 | Day |
Baseline Characteristics
Healthy control: subjects without autonomic dysfunction
RBD: patients with RBD diagnosis according to ICSD-3
Participant flow
We measured the electrocardiograms of patients with iRBD and healthy older people during an orthostatic challenge test, in which the supine and standing positions were held for 15 min, respectively. HRV measured in the supine position during the test were calculated by time-domain analysis and Poincare plots to evaluate the autonomic dysfunction.
Adverse events
None
Outcome measures
HRV, blood Pressure
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
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | 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
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034905
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