UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027098 |
|---|---|
| Receipt number | R000031058 |
| Scientific Title | Decrease effects of orexin receptor antagonist Suvorexant on masticatory muscle tone during bruxism or clench measured by portable polysomnography |
| Date of disclosure of the study information | 2017/04/22 |
| Last modified on | 2017/04/22 11:10:43 |
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Basic information
Public title
Decrease effects of orexin receptor antagonist Suvorexant on masticatory muscle tone during bruxism or clench measured by portable polysomnography
Acronym
Decrease effects of Suvorexant on muscle tone during bruxism or clench measured by polysomnography
Scientific Title
Decrease effects of orexin receptor antagonist Suvorexant on masticatory muscle tone during bruxism or clench measured by portable polysomnography
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takuro Endo |
Organization
Tokyo Sleep Medical Center
Division name
Sleep Clinic Chofu
Zip code
Address
2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL
0424900700
takuro@sleep-t.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Endo |
Organization
Tokyo Sleep Medical Center
Division name
Sleep Clinic Chofu
Zip code
Address
2-53-1 Kojima-cho Chofu-shi Tokyo 182-0026 Japan
TEL
0424900700
Homepage URL
http://www.sleepmedicine-tokyo.com/
takuro@sleep-t.com
Sponsor or person
Institute
Tokyo Sleep Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031058
