UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002053 |
|---|---|
| Receipt number | R000002500 |
| Scientific Title | Frequency of bruxism associated with changes in hemodynamics during sleep in hypoxia |
| Date of disclosure of the study information | 2009/06/09 |
| Last modified on | 2019/02/19 21:04:12 |
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Basic information
Public title
Frequency of bruxism associated with changes in hemodynamics during sleep in hypoxia
Acronym
Bruxism and hemodynamics during sleep in hypoxia
Scientific Title
Frequency of bruxism associated with changes in hemodynamics during sleep in hypoxia
Scientific Title:Acronym
Bruxism and hemodynamics during sleep in hypoxia
Region
| Japan |
Condition
Condition
sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether frequency of bruxism were altered when sleep in hypoxia and, if so, whether it attenuated a nocturnal reduction in blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen satiration and masseter muscle activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Normoxia during sleep (1 night)
Interventions/Control_2
Hypoxia (15.3%) during sleep (1 night)
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult applicants for a participation to this study.
Key exclusion criteria
Minor and those who have poor judgment.
Those who have personal history of cardiovascular and respiratory diseases.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu Uuniversity Graduate School of Medicine
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
Asahi 3-1-1, matsumoto, Japan
TEL
0263-37-2681
nosehir@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshi-ichiro Kamijo |
Organization
Shinshu University
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
Asahi 3-1-1, matsumoto, Japan
TEL
0263-37-2682
Homepage URL
yoshikmj@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Sports Medical Sciences, Institute on Aging and Adoptation, Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Matsumoto Dental University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2009 | Year | 06 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002500
