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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002053
Receipt No. 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

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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
Email 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
Email yoshikmj@shinshu-u.ac.jp

Sponsor
Institute Department of Sports Medical Sciences, Institute on Aging and Adoptation, Shinshu University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002500

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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