UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046149 |
|---|---|
| Receipt number | 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 | 2023/01/17 17:14:43 |
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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
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
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
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
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052675
