UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Decrease effects of orexin receptor antagonist Suvorexant on masticatory muscle tone during bruxism or clench measured by portable polysomnography
Title of the study (Brief title)	Decrease effects of Suvorexant on muscle tone during bruxism or clench measured by polysomnography
Region	Japan

Condition
Condition	bruxism or clench
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Dose orexin receptor antagonist Suvorxant decrease masticatory muscle tone during bruxism or clench?
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of masticatory muscle tone measured by portable polysomnography on orexin receptor antagonist using and not using nights on bruxism or clench patients using the antagonist for over one month.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Suvorxant using and the first withdrawal nights
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Bruxism diagnosed by The International Classification of Sleep Disorders Third Edition (ICSD-3)
Key exclusion criteria	The other sleep disorders
Target sample size	10

Research contact person
Name of lead principal investigator	Takuro Endo
Organization	Tokyo Sleep Medical Center
Division name	Sleep Clinic Chofu
Address	2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL	0424900700
Email	takuro@sleep-t.com

Public contact
Name of contact person	Takuro Endo
Organization	Tokyo Sleep Medical Center
Division name	Sleep Clinic Chofu
Address	2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL	0424900700
Homepage URL	http://www.sleepmedicine-tokyo.com/
Email	takuro@sleep-t.com

Sponsor
Institute	Tokyo Sleep Medical Center
Institute
Department

Funding Source
Organization	Geriatric dental medical institute
Organization
Division
Category of Funding Organization	Non profit foundation
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 04 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 14 Day
Anticipated trial start date	2017 Year 04 Month 22 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 04 Month 22 Day
Last modified on	2017 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031058