UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of Inhibitory effect of sleep hygiene instruction to sleep bruxism
Title of the study (Brief title)	Effect of sleep hygiene instruction to sleep bruxism
Region	Japan

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

Objectives
Narrative objectives1	To clarify the inhibitory effect of sleep bruxism by improving lifestyle (sleep hygiene instruction)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	number of sleep bruxism
Key secondary outcomes	Sleep efficiency, Apnea hypopnea index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Sleep hygiene instruction (1week)
Interventions/Control_2	without sleep hygiene instruction
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Student or staff in Tokushima University, and patient of Tokushima University Hospital Normal occlusion without missing tooth except for third molar and premolar (by orthodontic treatment)
Key exclusion criteria	patients who have pain except for orofacial pain in the morning patients who have mental desease patients who have medication that influences sleep patients who hve allegy to surface electrode pregnant patients patients who use pace maker
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshitaka Suzuki
Organization	Tokushima University Hospital
Division name	Dentistry
Address	3-18-15, Kuramoto-Cho, Tokushima, Tokushima, Japan
TEL	088-633-7350
Email	yosuzuki@tokushima-u.ac.jp

Public contact
Name of contact person	Yoshitaka Suzuki
Organization	Tokushima University Hospital
Division name	Dentistry
Address	3-18-15, Kuramoto-Cho, Tokushima, Tokushima, Japan
TEL	088-633-7350
Homepage URL
Email	yosuzuki@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2018 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 14 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	2018 Year 06 Month 12 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037565