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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040114
Receipt No. 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 2020/04/09

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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
Email 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
Email abe.takashi.gp@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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
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
2020 Year 03 Month 31 Day
Date of IRB
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
2020 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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