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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032959
Receipt No. R000037565
Scientific Title Investigation of Inhibitory effect of sleep hygiene instruction to sleep bruxism
Date of disclosure of the study information 2018/08/01
Last modified on 2018/06/12

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Basic information
Public title Investigation of Inhibitory effect of sleep hygiene instruction to sleep bruxism
Acronym Effect of sleep hygiene instruction to sleep bruxism
Scientific Title Investigation of Inhibitory effect of sleep hygiene instruction to sleep bruxism
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshitaka Suzuki
Organization Tokushima University Hospital
Division name Dentistry
Zip code
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
1st name
Middle name
Last name Yoshitaka Suzuki
Organization Tokushima University Hospital
Division name Dentistry
Zip code
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)

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
2018 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 14 Day
Date of IRB
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

Other
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

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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