UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057922 |
|---|---|
| Receipt number | R000066195 |
| Scientific Title | Examination of demand valve opening and closing conditions for efficient hydrogen inhalation using a nasal cannula |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/05/20 16:23:39 |
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Basic information
Public title
Examination of demand valve opening and closing conditions for efficient hydrogen inhalation using a nasal cannula
Acronym
Efficient hydrogen inhalation through a nasal cannula
Scientific Title
Examination of demand valve opening and closing conditions for efficient hydrogen inhalation using a nasal cannula
Scientific Title:Acronym
Efficient hydrogen inhalation through a nasal cannula
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although previous studies have reported on the safety and effectiveness of hydrogen inhalation, there is not enough clear evidence regarding the most efficient demand valve opening and closing sequence when inhaling hydrogen using a demand valve, or the amount of unabsorbed hydrogen discharged into the environment. This study will clarify the optimal demand valve opening and closing conditions to maximize the efficiency of hydrogen inhalation.
Basic objectives2
Others
Basic objectives -Others
This study will clarify the optimal demand valve opening and closing conditions to maximize the efficiency of hydrogen inhalation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjects will be asked to breathe at a respiratory rate of 12 to 30, while blood oxygen saturation and the hydrogen concentration in the air around the nasal cavity and oral cavity will be measured, and the valve control conditions that enable efficient inhalation while minimizing hydrogen leakage will be explored.
Venous blood samples will be taken from some of the subjects to measure blood hydrogen concentrations.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The study subjects will be asked to absorb approximately 2% hydrogen gas through a nasal cannula. A demand valve system will be used to supply hydrogen gas only when inhaling. The subjects will be asked to keep their breathing time constant by synchronizing it with a metronome. We will explore the demand valve opening and closing conditions that allow for the most efficient absorption of hydrogen.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a sufficient explanation of this study and have given their voluntary written consent after fully understanding it.
Key exclusion criteria
People with underlying respiratory or circulatory diseases.
People with a history of hyperventilation syndrome.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Yamaguchi University Graduate School of Medicine, Department of Health Sciences
Division name
Department of Clinical Labobatory Sciences
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
TEL
0836-22-2834
kenyama@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Yamaguchi University Graduate School of Medicine, Department of Health Sciences
Division name
Department of Clinical Labobatory Sciences
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
TEL
0834-22-2834
Homepage URL
kenyama@yamaguychi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
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
Yamaguchi University Graduate School of Medicine, Department of Health Sciences, Life Science and Medical Research Ethics Committee
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
Tel
0836-22-2007
me202@yamaguchi-u.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
| 2025 | Year | 05 | Month | 20 | 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
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066195
