UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057949 |
|---|---|
| Receipt number | R000066253 |
| Scientific Title | Biological Responses to High-Concentration Oxygen Inhalation |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/30 12:33:16 |
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Basic information
Public title
Biological Responses to High-Concentration Oxygen Inhalation
Acronym
Hyperoxia response
Scientific Title
Biological Responses to High-Concentration Oxygen Inhalation
Scientific Title:Acronym
Hyperoxia response
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although normobaric high-concentration oxygen is used in medical settings, it is also expected to have effects such as fatigue recovery in healthy individuals. As a result, temporary oxygen supplementation services, such as oxygen generators and oxygen capsules, have become readily available to the general public. However, excessive oxygen inhalation carries risks such as oxygen toxicity and the accumulation of oxidative stress. Therefore, in order to safely use oxygen in daily life, it is critically important to appropriately evaluate oxidative stress and oxygen toxicity.
This study aims to analyze changes in exhaled components before and after oxygen inhalation, investigate the production dynamics of supersulfide metabolites and oxidative stress biomarkers in exhaled breath, and establish a non-invasive method for evaluating oxygen stress. Ultimately, the goal is to assess the oxygen tolerance capacity of healthy individuals exposed to oxygen inhalation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study focuses on metabolites contained in exhaled breath condensate, particularly sulfur-containing metabolites.
Exhaled breath condensate will be collected from 10 individuals and promptly analyzed using mass spectrometry to quantify various metabolites and assess changes induced by a 120-minute exposure to 40% oxygen.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
After having breakfast:
Exhaled breath condensate will be collected for 20 minutes starting at 8:40 a.m.
From 9:00 a.m. to 11:00 a.m., subjects will inhale 40% oxygen for 120 minutes. During this period, exhaled breath condensate will be collected concurrently in six intervals: 0-20 minutes, 20-40 minutes, 40-60 minutes, 60-80 minutes, 80-100 minutes, and 100-120 minutes from the start of oxygen inhalation.
Immediately after the completion of oxygen inhalation, exhaled breath condensate will be collected for another 20 minutes.
An additional 20-minute breath condensate sample will be collected starting 60 minutes after the end of oxygen inhalation.
The procedure will conclude at 12:20 p.m.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged 20 to 40 years at the time of enrollment
Key exclusion criteria
Not currently taking any medications
Not undergoing dental treatment
Willing to refrain from alcohol consumption and strongly flavored foods such as garlic during the study period
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hozumi |
| Middle name | |
| Last name | Motohashi |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
81-22-717-8089
hozumi.motohashi.a7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hozumi |
| Middle name | |
| Last name | Motohashi |
Organization
Tohoku University
Division name
Graduate School of Meicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
81-22-717-8089
Homepage URL
hozumi.motohashi.a7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
DAIKIN
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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 | 10 | Month | 30 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 29 | 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 | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066253
