UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022682 |
|---|---|
| Receipt number | R000026142 |
| Scientific Title | Health promotion through sleep quality intervention. - Sleep intervention through multi modal evaluation using a pseudo daily life space - |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2019/11/21 08:13:01 |
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Basic information
Public title
Health promotion through sleep quality intervention.
- Sleep intervention through multi modal evaluation using a pseudo daily life space -
Acronym
Comfortable sleep intervention.
Scientific Title
Health promotion through sleep quality intervention.
- Sleep intervention through multi modal evaluation using a pseudo daily life space -
Scientific Title:Acronym
Comfortable sleep intervention.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In pseudo daily life space laboratory, paticipants carry out sleep introduction training using the technique of mind Fullness to the young man with the tendency to sleeplessness and compare the quality of the sleep.
Compare the quality of the sleep with the group which raised carbon dioxide density in the room in a normal group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain waves and heartbeat
Key secondary outcomes
Motion analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mind fullness, 1 week
Interventions/Control_2
carbon dioxide density, one night.
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
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
The right-handed male university student whom a tendency to sleeplessness person, score of Pittsburgh Sleep Quality Index beat more than six points 20 years or older
Key exclusion criteria
The person who carries out the person of the antibiotic of dosage, a smoker, a going to hospital person, food allergy, a medicine for intestinal disorders user, other sleep introduction technique within person whom an insomniac diagnosis is given to, the past one month
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku university graduateschool of biomedical engineering
Division name
health and welfare
Zip code
Address
2-1 Seiryo-machi Aoba-ku Senndai-shi Miyagi-ken
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Muratsubaki |
Organization
Tohoku university graduateschool of medicine
Division name
Ethics and Educational Objective of School of Medicine
Zip code
Address
2-1 Seiryo-machi Aoba-ku Senndai-shi Miyagi-ken
TEL
022-717-8162
Homepage URL
t-mura@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Biomedical Engineering for Health & Welfare,
Tohoku University Graduate School of Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency, Center of innovattion
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学レジリエント社会構築イノベーションセンター、疑似日常空間実験室
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2017 | 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
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026142
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
