UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058917 |
|---|---|
| Receipt number | R000067296 |
| Scientific Title | A Prospective, Single-Blind, Interventional Comparative Trial Aiming to Establish Safety Standards for Hypoxic Chamber Operation |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/28 15:12:38 |
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Basic information
Public title
A Comparative Study to Establish Safe Use Methods and Verify the Effects of Hypoxic Chambers
Acronym
A Study on the Safe Operation and Effectiveness of Hypoxic Chambers
Scientific Title
A Prospective, Single-Blind, Interventional Comparative Trial Aiming to Establish Safety Standards for Hypoxic Chamber Operation
Scientific Title:Acronym
Randomized Controlled Trial of Hypoxic Chambers
Region
| Japan |
Condition
Condition
Healthy adults will be enrolled.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypoxic chambers have become widely used for the purpose of enhancing athletic performance. In recent years, their use has expanded to the general population for health promotion, and an increasing number of fitness gyms are now equipped with hypoxic chambers. However, cases of use in unmanned gyms and at home have also been observed, and standardized safety guidelines for their operation have not yet been established. Furthermore, the scientific evidence supporting claims of improvement in diabetes, hypertension, and obesity through continued use for commercial purposes remains limited.
This study aims to establish safety standards for the operation of hypoxic chambers and to verify their effectiveness in lifestyle-related diseases. We will conduct a questionnaire survey on hypoxia awareness among healthy individuals and implement a three-week intermittent hypoxic intervention using hypoxic chambers equipped with an original safety management system. The primary outcome measures will include psychological burden associated with hypoxic exposure, circadian blood glucose variability, blood pressure, and body weight.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circadian blood glucose variability will be assessed during a three-week intervention consisting of hypoxic exposure for 1 hour per day, 5 days per week.
Key secondary outcomes
Changes in blood oxygen saturation and blood pressure will be examined during a three-week intervention consisting of hypoxic exposure for 1 hour per day, 5 days per week.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will stay in a hypoxic chamber for 1 hour per day, 5 days per week, for 3 weeks.
Interventions/Control_2
Participants will stay in a hypoxic chamber for 1 hour per day, 5 days per week, for 3 weeks.
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
1. Healthy individuals without a history of cardiovascular, internal medicine, or respiratory diseases
2. Aged 20 years or older and 65 years or younger at the time of enrollment
3. Not on any regular medication
4. Able to provide written informed consent for study participation
Key exclusion criteria
Participants meeting the following conditions will be excluded due to anticipated vulnerability or hypersensitivity to hypoxic exposure:
1. History of cardiovascular or respiratory disease, or currently under treatment for such conditions
2. Current smoking habit
3. History of an acute internal medicine illness (e.g., cold, bronchitis, or other infection) requiring medical consultation within the past two weeks
Participants meeting the following conditions will be excluded as they may affect the evaluation of effectiveness:
1. Currently under treatment for diabetes mellitus or hypertension
2. Regular use of medication
3. Claustrophobia
4. Metal allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Nakai |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Oxygen Biology
Zip code
981-8003
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi-ken
TEL
0227178206
taku.nakai.e7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Nakai |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Oxygen Biology
Zip code
981-8003
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi-ken
TEL
0227178206
Homepage URL
taku.nakai.e7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Regenesom Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Clinical Research Ethics Committee
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi-ken
Tel
022-717-7122
ec-hosp@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 | 09 | Month | 01 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067296
