UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041302 |
|---|---|
| Receipt number | 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 | 2021/06/29 07:36:48 |
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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
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
suzuki.hiroshi91@nihon-u.ac.jp
Sponsor or person
Institute
Division of Oral Function and Rehabilitation,
Department of Oral Health Science,
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047164
| 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 |
