UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060246 |
|---|---|
| Receipt number | R000068365 |
| Scientific Title | Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/03 08:34:02 |
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Basic information
Public title
Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial
Acronym
Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial
Scientific Title
Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial
Scientific Title:Acronym
Effects of O2 Box on Sleep: An Open-Label Randomized Controlled Trial
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of exposure to a hyperbaric oxygen environment on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
St. Mary's Hospital Sleep Questionnaire at Baseline and Follow-up (Day 0, Day 8)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exposure to a hyperbaric oxygen chamber environment at 1.3 atmospheres (1 hour)
Interventions/Control_2
Do not enter the oxygen chamber
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,At the time of consent acquisition, age is 18 years or older and 40 years or younger
2,Individuals who, after receiving sufficient explanation regarding participation in this research, provided written consent of their own free will based on full understanding
Key exclusion criteria
1,Individuals taking medications that affect sleep (such as sleeping pills)
2,Individuals planning to consume alcohol during the study period
3, Individuals suffering from diseases that cause sleep disorders
4, Individuals with a BMI of 30 or higher.
5, Individuals deemed unsuitable as research subjects by the principal investigator
6, Individuals who used this device within one week prior to the pre-observation date
7, Among the research subjects meeting the above (1), eligibility is determined by satisfying all (2) selection criteria and not meeting any (3) exclusion criteria.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Nagao |
Organization
Juntendo University
Division name
Department of Sports Medicine
Zip code
113-8421
Address
Hongo 2-1-1, Bunkyo-Ku, Tokyo
TEL
+81-3-3813-3111
nagao@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Nagao |
Organization
Juntendo University
Division name
Department of Sports Medicine
Zip code
113-8421
Address
Hongo 2-1-1, Bunkyo-Ku, Tokyo
TEL
+81-3-3813-3111
Homepage URL
nagao@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Time World, Co, Ltd
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
Juntendo University Graduate School of Medicine Institutional Review Board
Address
Hongo 2-1-1, Bunkyo-Ku, Tokyo
Tel
+81-3-3813-3111
hongo-rinri@juntendo.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
| 2026 | Year | 01 | Month | 05 | 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 | 18 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | 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
| 2026 | Year | 01 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068365
