UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057064 |
|---|---|
| Receipt number | R000065192 |
| Scientific Title | Effects of neck warming and cooling stimulation on the operating point of the arterial baroreflex |
| Date of disclosure of the study information | 2025/02/18 |
| Last modified on | 2025/02/18 16:59:02 |
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Basic information
Public title
Effects of neck warming and cooling stimulation on the operating point of the arterial baroreflex
Acronym
Effects of neck warming and cooling stimulation on the operating point of the arterial baroreflex
Scientific Title
Effects of neck warming and cooling stimulation on the operating point of the arterial baroreflex
Scientific Title:Acronym
Warming and cooling stimulation and arterial baroreflex
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study examines the effects of neck warming and cooling stimulation on the operating point of the arterial baroreflex
Basic objectives2
Others
Basic objectives -Others
The study also examines the relationship between the operating point of the arterial baroreflex and cerebral blood flow
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The operating point of the arterial baroreflex
cardiovascular variables (blood pressure, stroke volume, cardiac output, total peripheral resistance)
cerebral blood flow velocity
respiratory variables (tidal volume, respiratory rate, ventilation volume, end tidal CO2)
body temperature (core temperature, skin temperature)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The neck is warmed for 20 seconds.
Interventions/Control_2
The neck is warmed for 60 seconds.
Interventions/Control_3
The neck is cooled for 20 seconds.
Interventions/Control_4
The neck is cooled for 60 seconds.
Interventions/Control_5
The back of the neck is warmed for 20 seconds.
Interventions/Control_6
The back of the neck is warmed for 60 seconds.
Interventions/Control_7
The back of the neck is cooled for 20 seconds.
Interventions/Control_8
The back of the neck is cooled for 60 seconds.
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male aged 18-39
Key exclusion criteria
Smoker
Those who take medication
Those who have chronic diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamura |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6833
nnakamura@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamura |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6833
Homepage URL
nnakamura@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Waseda University, Ethics Review Committee on Research with Human Subjects
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2025 | Year | 02 | Month | 18 | 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
| 2024 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065192
