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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046149
Receipt No. R000052675
Scientific Title The effect of hypocapnia and cerebral hypoperfusion on thermal sensation in normothermic human
Date of disclosure of the study information 2021/11/23
Last modified on 2021/11/23

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Basic information
Public title The effect of hypocapnia and cerebral hypoperfusion on thermal sensation in normothermic human
Acronym The effect of hypocapnia on thermalsensation in normothermic human
Scientific Title The effect of hypocapnia and cerebral hypoperfusion on thermal sensation in normothermic human
Scientific Title:Acronym The effect of hypocapnia on thermalsensation in normothermic human
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of a decrease in the partial pressure of CO2 in arterial blood and a concomitant decrease in cerebral blood flow on temperature perception at normothermia.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Local skin thermal sensation is measured during normal breathing, during hypocapnia associated with hyperventilation, and when maintaining normal carbon dioxide status during hyperventilation.
Key secondary outcomes Esophageal and skin temperature, mwan arterial blood pressure, heart rate, minute ventilation, end-tidal CO2 partial pressure are measured during normal breathing, during hypocapnia associated with hyperventilation, and when maintaining normal carbon dioxide status during hyperventilation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 voluntary hyperventilation
Interventions/Control_2 CO2 inhalation
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
30 years-old >=
Gender Male and Female
Key inclusion criteria No respiratory disease, no daily medication and no smoking history
Key exclusion criteria Those with respiratory diseases, those who take medication on a daily basis, and those with a history of smoking
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Fujimoto
Organization Niigata University of Health and Welfare
Division name Department of Health and Sports
Zip code 950-3198
Address Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL 025-257-4675
Email fujimoto@nuhw.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Fujimoto
Organization Niigata University of Health and Welfare
Division name Department of Health and Sports
Zip code 950-3198
Address Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL 025-257-4675
Homepage URL
Email fujimoto@nuhw.ac.jp

Sponsor
Institute Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization Advanced Research Initiative for Human High Performance (ARIHHP), University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Niigata University of Health and Welfare
Address Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel 025-257-4675
Email fujimoto@nuhw.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
2021 Year 11 Month 23 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 23 Day
Last modified on
2021 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052675

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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