UMIN-CTR Clinical Trial

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
Email	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
Email	t-mura@med.tohoku.ac.jp

Sponsor
Institute	Division of Biomedical Engineering for Health & Welfare, Tohoku University Graduate School of Biomedical Engineering
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026142