UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Title of the study (Brief title)	The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of Suvorexant on physical and cognitive functions after nocturnal forced-awakening
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The executive function 90 minutes after taking a pill (Stroop color-word test)
Key secondary outcomes	The physical functions 90 minutes after taking a pill (Balance ability, dexterity, reaction time, walking ability) Polysomnography (Sleep latency, sleep architecture)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer placebo (lactose)
Interventions/Control_2	Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer placebo (lactose) - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg
Interventions/Control_3	Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer placebo (lactose)
Interventions/Control_4	Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer placebo (lactose) - Wash out (more than 2 days) - Administer Suvorexant 20 mg
Interventions/Control_5	Administer placebo (lactose) - Wash out (more than 2 days) - Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg
Interventions/Control_6	Administer placebo (lactose) - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer Suvorexant 20 mg
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	1)Healthy men aged 18-40years old 2)Standard body size(BMI < 25 kg/m2) 3)Free from subjective sleep complaints (PSQI < 6 points) 4)Free from medical history of Sleep apnea syndrome 5)Participants who do not take sleeping pills 6)Participants whose sleep latency are 10 minutes or less 7)Morning people (MEQ > 59 points) 8)Habitual exercise 2 times or less a week for the past 6 months 9)Habitual drinking less than 3 times a week 10)No habitual smonking
Key exclusion criteria	1)Participants who are taking a pill to inhibit CYP3A 2)Acute angle crose glaucoma 3)Myasthenia gravis
Target sample size	30

Research contact person
Name of lead principal investigator	Tomohiro Okura
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-2660
Email	okura@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Tomohiro Okura
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-2660
Homepage URL
Email	okura@taiiku.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Faculty of health and sport sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	International Institute for Integrative Sleep Medicine (IIIS)
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	筑波大学（茨城県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 07 Month 01 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	2016 Year 06 Month 15 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026179