UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059793 |
|---|---|
| Receipt number | R000068362 |
| Scientific Title | Acute Effects of Normobaric Hypoxia on Skeletal Muscle Microvascular Function |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/16 11:52:00 |
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Basic information
Public title
Acute Effects of Normobaric Hypoxia on Skeletal Muscle Microvascular Function
Acronym
Acute Effects of Normobaric Hypoxia on Skeletal Muscle Microvascular Function
Scientific Title
Acute Effects of Normobaric Hypoxia on Skeletal Muscle Microvascular Function
Scientific Title:Acronym
Acute Effects of Normobaric Hypoxia on Skeletal Muscle Microvascular Function
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the acute effects of hypoxic exposure on skeletal muscle microvascular function, thereby contributing to understanding the impact of hypoxic exposure on vascular function in modern society.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microvascular Function of the Gastrocnemius Muscle Before and After Exposure to 15% Oxygen Concentration
Key secondary outcomes
Heart rate, stroke volume, cardiac output, mean arterial pressure, and SpO2 before and after a 10-minute exposure intervention at 15% inspired oxygen concentration, and during the intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Attach a mask to a balloon filled with air containing 15% oxygen concentration and inhale the air from the balloon for 10 minutes.
Interventions/Control_2
Do not connect to the balloon; inhale room air for 10 minutes.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must be between 18 and 30 years of age at the time consent is obtained.
Participants must have received a thorough explanation regarding this research and provided written consent of their own free will after demonstrating sufficient understanding.
Key exclusion criteria
Individuals aged 31 years or older
Individuals with a history of cardiovascular disease or currently receiving medication for such conditions
Individuals currently taking medication or supplements
Individuals with a regular exercise routine (performing at least 150 minutes of moderate-intensity aerobic exercise or 75 minutes of vigorous-intensity aerobic exercise per week)
Individuals with a history of smoking
Other individuals deemed unsuitable for the study by the principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Yoshino |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Studies Department of Health Sciences Division of Physical Therapy
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
090-6795-4327
hpm25022@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoshino |
| Middle name | |
| Last name | Takuro |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
090-6795-4327
Homepage URL
hpm25022@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
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
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
info@nihw.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 | 11 | Month | 17 | 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 | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068362
