UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040114 |
|---|---|
| Receipt number | R000045738 |
| Scientific Title | Evaluation of sleep using the mobile sleep laboratory for human |
| Date of disclosure of the study information | 2020/04/09 |
| Last modified on | 2023/04/12 10:48:22 |
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Basic information
Public title
Sleep evaluation using the mobile sleep laboratory for human
Acronym
Evaluation of sleep using the mobile sleep laboratory for human
Scientific Title
Evaluation of sleep using the mobile sleep laboratory for human
Scientific Title:Acronym
Evaluation of sleep using the mobile sleep laboratory for human
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and evaluate sleep architectures measured in a mobile and a normal sleep laboratory
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Experiment 1]
1)Sleep variables such as sleep latency, percentage of sleep stages and wake after sleep onset evaluated by polysomnography
2)Spectral power density from frequency analysis using Electroencephalographic recordings for each sleep stage
[Experiment 2]
Spectral power density from frequency analysis using Electroencephalographic recordings for each sleep stage
Key secondary outcomes
[Experiment 1]
1)Evaluation of equivalence by inctraclass correlation coefficient and Bland-Altman analysis using sleep variables in the same room
2)Evaluation of equivalence by inctraclass correlation coefficient and Bland-Altman analysis using sleep variables in the different rooms
3)Questionnaires (Morning-Eveningness Questionnaire, Pittsburgh Sleep Quality Index and OSA sleep inventory)
4)Evaluation of sleep/wake using wrist-watch type actigraphy
[Experiment 2]
Questionnaires (Morning-Eveningness Questionnaire, Pittsburgh Sleep Quality Index and OSA sleep inventory)
[Experiment 1,2]
Vibration, noise, temperature and humidity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
[Experiment 1]
A.normal sleep laboratory
B.mobile sleep laboratory
Subjects stay 2 nights (total 4 nights/ subject) in each laboratory. The order of laboratory is (A,B).
[Experiment 2]
A.normal sleep laboratory
B.mobile sleep laboratory
Subjects stay 1 nights (total 2 nights/ subject) in each laboratory. The order of laboratory is (A,B).
Interventions/Control_2
[Experiment 1]
The order of laboratory is (B,A).
[Experiment 2]
The order of laboratory is (B,A).
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants will be included on the following all criteria.
1)Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2)Being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba, and the mobile human sleep laboratory at the Japan Automobile Research Institute.
3)Having no sleep disorder currently being treated
4)(Experiment 1 only) having never experienced sleep EEG recording (polysomnography, PSG)
Key exclusion criteria
Participants will be excluded from the experiment based on the following criteria.
1)Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am, 7-9 hours of sleep)
2)BMI less than 18.5 or greater than 25
3)Worked night shifts (after 10pm) 3 months prior to the experiment
4)Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment
5)Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more)
6)Smoker
7)Consumes more than 300mg (5 cups of 150mL) of coffee every day
8)Have possibilities that correspond to 1-7) above during the experiment period
9)MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
10)Pittsburgh Sleep Quality Index score of greater than 5.5
11)Have a disease that may change suddenly or its history
12)Claustrophobic
13)Pregnancy or its possibility
14)Lactation
15)Subjects judged by the investigator to be inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8575
Address
Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-859-1858
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8575
Address
Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-859-1858
Homepage URL
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
TOYOTA MOTOR CORPORATION
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
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address
Amakubo, Tsukuba, Ibaraki 305-5876, Japan
Tel
029-853-3914
jisedai@md.tsukuba.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
| 2020 | Year | 04 | Month | 09 | 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
20
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
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045738
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| Registered date | File name |
| Research case data | |
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