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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041302
Receipt No. R000047164
Scientific Title Effects of Acupuncture Stimulation of Masticatory Muscles on Sleep and Sleep Blaxism
Date of disclosure of the study information 2020/08/04
Last modified on 2020/08/04

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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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 12 Month 29 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
2020 Year 08 Month 04 Day


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

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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