UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032793 |
|---|---|
| Receipt number | R000037380 |
| Scientific Title | Accuracy of portable PSG device for detection of sleep bruxism-related masseter EMG muscle activity |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2022/06/09 22:43:02 |
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Basic information
Public title
Accuracy of portable PSG device for detection of sleep bruxism-related masseter EMG muscle activity
Acronym
Accuracy of portable PSG device for detection of sleep bruxism
Scientific Title
Accuracy of portable PSG device for detection of sleep bruxism-related masseter EMG muscle activity
Scientific Title:Acronym
Accuracy of portable PSG device for detection of sleep bruxism
Region
| Japan |
Condition
Condition
Sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate accuracy of the portable PSG device for scoring sleep bruxism-related masseter EMG muscle activity in comparison to the polysomnography.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep brusixm episodes based on the masseter EMG activity during sleep
Key secondary outcomes
Total sleep time, sleep efficiency, sleep latency, sleep stage
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Less than two missing molars
Those who gave written informed consent in first-person
Key exclusion criteria
Use of a removable dental prosthesis
Ongoing dental therapy, including orthodontic treatment
Major neurological, psychiatric or sleep disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
145-8515
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
0337871151
abeyuka@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
145-8515
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
03-3787-1151
Homepage URL
abeyuka@dent.showa-u.ac.jp
Sponsor or person
Institute
Department of Prosthodontics, Showa University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University
Name of secondary funder(s)
Showa University, Osaka University
IRB Contact (For public release)
Organization
Ethics Committee of Showa University
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
Tel
0337871151
abeyuka@dent.showa-u.ac.jp
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 | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The participants spend two nights in a sleep laboratory for audio-video polysomnography (PSG) recordings with additional masseter muscle EMG recording. The first night data is used to make definite diagnosis of sleep bruxism status according to sleep bruxism research diagnostic criteria. The second night recording is conducted by the regular PSG setting simultaneously with the portable PSG device.
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
