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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032793
Receipt No. R000037380
Official scientific title of the study 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 2018/05/30

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Basic information
Official scientific title of the study Accuracy of portable PSG device for detection of sleep bruxism-related masseter EMG muscle activity
Title of the study (Brief title) 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 Yuka Abe
Organization Showa University
Division name Department of Prosthodontics
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL 03-3787-1151
Email abeyuka@dent.showa-u.ac.jp

Public contact
Name of contact person Yuka Abe
Organization Showa University
Division name Department of Prosthodontics
Address 2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL 03-3787-1151
Homepage URL
Email abeyuka@dent.showa-u.ac.jp

Sponsor
Institute Department of Prosthodontics, Showa University
Institute
Department

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

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 12 Month 16 Day
Anticipated trial start date
2015 Year 04 Month 09 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 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
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037380

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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