UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Acupuncture Stimulation of Masticatory Muscles on Sleep and Sleep Blaxism
Acronym	Effects of Acupuncture Stimulation of Masticatory Muscles on Sleep and Sleep Blaxism
Scientific Title	Effects of Acupuncture Stimulation of Masticatory Muscles on Sleep and Sleep Blaxism
Scientific Title:Acronym	Effects of Acupuncture Stimulation of Masticatory Muscles on Sleep and Sleep Blaxism
Region	Japan

Condition
Condition	Sleep Blaxism
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the effects of acupuncture on the masticatory muscles on their occlusal state and muscle hardness, as well as changes in the state of sleep-disordered breathing and sleep-braxism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes in the sleep-braxism.
Key secondary outcomes	changes in the state of sleep-disordered breathing.

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Numbered container method

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	acupuncture
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Mental and physical health Snoring, sleep apnea, or teeth grinding
Key exclusion criteria	Those who are treated for missing teeth and have dentures or implants. Those who are receiving medication due to psychological disorders Those who have had a difficult experience with acupuncture in the past
Target sample size	100

Research contact person
Name of lead principal investigator	1st name HIROSHI Middle name Last name SUZUKI
Organization	Nihon University School of Dentistry at Matsudo
Division name	Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code	271-8587
Address	2-870-1 Sakaecho-Nishi Matsudo-shi
TEL	047-360-9642
Email	suzuki.hiroshi91@nihon-u.ac.jp

Public contact
Name of contact person	1st name HIROSHI Middle name Last name SUZUKI
Organization	Nihon University School of Dentistry at Matsudo
Division name	Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code	270-8587
Address	2-870-1 Sakaecho-Nishi Matsudo-shi
TEL	047-360-9642
Homepage URL
Email	suzuki.hiroshi91@nihon-u.ac.jp

Sponsor
Institute	Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization	Nihon University School of Dentistry at Matsudo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University School of Dentistry at Matsudo
Address	2-870-1 Sakaechi-Nishi, Matsudo-shi
Tel	047-360-9642
Email	suzuki.hiroshi91@nihon-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	2020 Year 08 Month 04 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	Suspended
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 08 Month 16 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 04 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047164