UMIN-CTR Clinical Trial

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
Email	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
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

IRB Contact (For public release)
Organization	Ethics Committee of Showa University
Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo
Tel	0337871151
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037380