UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of improvement program for sleeping habits of college students
Title of the study (Brief title)	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	Keiko Murai
Organization	Kobe Gakuin Univ.
Division name	The Faculty of Humanities and Sciences
Address	518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL	078-974-1551
Email	murai@human.kobegakuin.ac.jp

Public contact
Name of contact person	Saki Tenma
Organization	Kobe Gakuin Univ.
Division name	The Graduate Scholl of Humanities and Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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