UMIN-CTR Clinical Trial

Basic information
Public title	Effects of differences in autonomic nervous system activity on diving reflex
Acronym	Effects of differences in autonomic nervous system activity on diving reflex
Scientific Title	Effects of differences in autonomic nervous system activity on diving reflex
Scientific Title:Acronym	Effects of differences in autonomic nervous system activity on diving reflex
Region	Japan

Condition
Condition	diving reflex
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of autonomic nervous activity changed by low to moderate intensity exercise on the appearance of diving reflex
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart rate before and during face cooling
Key secondary outcomes	Blood pressure and Pulse wave velocity before and during face cooling Autonomic nerve system activity before face cooling

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	low intensity exercise (applox.5min, once) and face cooling (1min, twice)
Interventions/Control_2	moderate intensity exercise (applox.15min, once) and face cooling (1min, twice)
Interventions/Control_3	no exercise and face cooling (1min, twice)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Student of Tokyo University of marine science and technology and age of over 20 years of adult 2.Participants is fully informed about the study and has singed the informed consent form 3.Participant who can carry out study and manage their own physical condition in the schedule presented by researcher 4.Participant who sign up for Personal Accident Insurance for Students Pursuing Education and Research or equivalent insurance 5.Resting heart rate is 50 to 100bpm immediately before measurement 6.Resting blood pressure is less than 140/80 immediately before measurement 7.Participant has enough sleep the day before measurement 8.At least 2 hours have passed from eating 9.With no drinking 10.With no taking caffeine or at least 2 hours has passed from taking
Key exclusion criteria	1.Person who satisfy the inclusion criteria above 2.Person who is given class credits by the research supervisor during reserch period
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name FUJIMOTO
Organization	Tokyo University of Marine Science and Technology
Division name	Department of Marine Policy and Culture
Zip code	108-8477
Address	4-5-7, Kownan, Minato-ku
TEL	03-5463-0638
Email	kfujim1@kaiyodai.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name FUJIMOTO
Organization	Tokyo University of Marine Science and Technology
Division name	Department of Marine Policy and Culture
Zip code	108-8477
Address	4-5-7, Kownan, Minato-ku
TEL	03-5463-0638
Homepage URL
Email	kfujim1@kaiyodai.ac.jp

Sponsor
Institute	Tokyo University of Marine Science and Technology
Institute
Department

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	Tokyo University of Marine Science and Technology Research Ethics Committee
Address	4-5-7, Kownan, Minato-ku
Tel	03-5463-4197
Email	ke-ken@o.kaiyodai.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	2020 Year 06 Month 08 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	10
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	Completed
Date of protocol fixation	2019 Year 08 Month 29 Day
Date of IRB	2019 Year 08 Month 29 Day
Anticipated trial start date	2019 Year 08 Month 29 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 06 Day
Last modified on	2020 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046415