UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017245 |
|---|---|
| Receipt number | R000020009 |
| Scientific Title | Craniofacial Pain and Jaw-muscle Activity during Sleep |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2015/04/22 17:46:55 |
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Basic information
Public title
Craniofacial Pain and Jaw-muscle Activity during Sleep
Acronym
Craniofacial Pain and Jaw-muscle Activity during Sleep
Scientific Title
Craniofacial Pain and Jaw-muscle Activity during Sleep
Scientific Title:Acronym
Craniofacial Pain and Jaw-muscle Activity during Sleep
Region
| Japan |
Condition
Condition
healthy individuals, tension type headache patients, temporomandibular disorders
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main aim of this short-term observational study was to compare the
jaw-muscle EMG activity during sleep between patients with or without painful
TMD or TTH and in healthy control individuals.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electrical jaw-muscle activity during sleep
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
electromyography
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
generally healthy
Key exclusion criteria
history of neurologic or psychiatric disorders, sleep disorders, medication or coffee takers
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Arima |
Organization
Hokkaido University
Division name
Graduate School of Dental Medicine
Zip code
Address
North13 West7, Kita-ku, Sapporo
TEL
0117064275
tar@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Arima |
Organization
Hokkaido University
Division name
Graduate School of Dental Medicine
Zip code
Address
North13 West7, Kita-ku, Sapporo
TEL
0117064275
Homepage URL
tar@den.hokudai.ac.jp
Sponsor or person
Institute
Aarhus University
Institute
Department
Personal name
Funding Source
Organization
Aarhus University
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | 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
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2015 | 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=R000020009
