UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045478 |
|---|---|
| Receipt number | R000051919 |
| Scientific Title | Analysis of the effect of carbon dioxide exposure on daytime sleepiness using multiple sleep latency test |
| Date of disclosure of the study information | 2021/09/14 |
| Last modified on | 2023/10/04 11:21:06 |
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Basic information
Public title
Analysis of the effect of carbon dioxide exposure on daytime sleepiness using multiple sleep latency test
Acronym
Analysis of the effect of carbon dioxide exposure on daytime sleepiness using multiple sleep latency test
Scientific Title
Analysis of the effect of carbon dioxide exposure on daytime sleepiness using multiple sleep latency test
Scientific Title:Acronym
Analysis of the effect of carbon dioxide exposure on daytime sleepiness using multiple sleep latency test
Region
| Japan |
Condition
Condition
Sleeping disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to obtain clinically valid and reliable data on the effects of low-level carbon dioxide exposure on daytime sleepiness using multiple sleep latency test.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep latency in multiple sleep latency test, subjective sleepiness, and objective sleepiness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exposure to air for 30 min, 4 times
Interventions/Control_2
Exposure to 5,000 ppm CO2 for 30 min, 4 times
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male between the ages of 20 and 35 years old who can voluntarily decide whether or not to participate in the study.
No history of sleep disorders, neurological, cardiovascular, or respiratory diseases.
Non-smoker
No more than 400 mg of caffeine per day for 7 days prior to the start of the experiment, and no more than 3 days per week.
(3 cups or less of coffee, 8 cups or less of green or black tea, 5 bottles or less of Red Bull, 2 bottles or less of Monster Energy)
Less than 5 days of drinking in the past month
BMI less than 30
No long-term use of sleeping pills or melatonin
Key exclusion criteria
Sleeping less than 6 hours for 4 or more days as a result of controlled bedtime/wake activity and activity meter sleep recording (7 days) before the study
Subjects who consumed caffeine or alcohol on the day before the experiment
Subjects who slept less than 6 hours on the day before the experiment.
Subjects who showed "signs" of sleep disorder in the all-night polysomnography.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku Sendai, Miyagi
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Inada |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku Sendai, Miyagi
TEL
022-717-8203
Homepage URL
hinada@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Clinical Research Ethics Committee, Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku Sendai, Miyagi
Tel
022-728-4105
ec@rinri.hosp.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
| 2021 | Year | 09 | Month | 14 | 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
13
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051919
