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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030053
Receipt No. R000034281
Scientific Title The effect of improvement program for sleeping habits of college students
Date of disclosure of the study information 2017/11/20
Last modified on 2019/02/05

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Basic information
Public title The effect of improvement program for sleeping habits of college students
Acronym The effect of improvement program for sleeping habits of college students
Scientific Title The effect of improvement program for sleeping habits of college students
Scientific Title:Acronym The effect of improvement program for sleeping habits of college students
Region
Japan

Condition
Condition N/A (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of the improvement program for deleterious sleeping habits of college students with a nocturnal lifestyle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 8-week daily sleep diary recorded by subjects
Key secondary outcomes 4 questionnaires (Pittsburgh Sleep Quality Index, Athens Insomnia Scale, The Epworth Sleepiness Scale, DAIHAL.2) are conducted on the first day, the last day and the follow-up day of the program.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Improvement program for sleeping habits of college students
Interventions/Control_2
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
18 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria College students without insomnia but with difficulty awaking in the morning
Key exclusion criteria Nothing
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Murai
Organization Kobe Gakuin Univ.
Division name The Faculty of Humanities and Sciences
Zip code
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL 078-974-1551
Email murai@human.kobegakuin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saki Tenma
Organization Kobe Gakuin Univ.
Division name The Graduate Scholl of Humanities and Sciences
Zip code
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL 078-974-1551
Homepage URL
Email h8smsn03@s.human.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin Univ.
Institute
Department

Funding Source
Organization Kobe Gakuin Univ.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 11 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 Completed
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034281

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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