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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023512
Receipt No. R000027041
Scientific Title Analysis of breathing and jaw movement during sleep in xerostomia
Date of disclosure of the study information 2016/11/16
Last modified on 2018/08/07

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Basic information
Public title Analysis of breathing and jaw movement during sleep in xerostomia
Acronym Analysis of breathing and jaw movement during sleep in xerostomia
Scientific Title Analysis of breathing and jaw movement during sleep in xerostomia
Scientific Title:Acronym Analysis of breathing and jaw movement during sleep in xerostomia
Region
Japan

Condition
Condition Xerostomia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of xerostomia treatment (oral cavity moisturizing) improvement of breathing disorders and sleep bruxism during sleep
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes SpO2, AHI, Number of sleep bruxism event before and after treatment
Key secondary outcomes Quality of sleep (total sleep time, sleep efficiency, sleep latency)
Chin oral function system disorders (tooth of attrition, masticatory muscle pain, fatigue, tension headache)

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 medicine peptisal
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Those who visit for the periodic inspection in Tokushima University Hospital Dental
Those who can participate in the sleep measurement of 2 days
A person who has a personality normal occlusion
Key exclusion criteria Micrognathia
Those with jaw dysfunction
obesity
Those who are regular a sleep-inducing agent
Who is not suffering from a neuropsychiatric disorders
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsuka, Yoshizo
Organization Tokushima University
Division name Department of Stomatognathic Function and Occlusal Reconstruction, Graduate Schoo
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, Tokushima, Japan
TEL 088-633-7350
Email matsuka@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okura, Kazuo
Organization tokushima University
Division name Department of Stomatognathic Function and Occlusal Reconstruction, Graduate Schoo
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, Tokushima, Japan
TEL 088-633-7350
Homepage URL
Email okura.kazuo@tokushima-u.ac.jp

Sponsor
Institute Department of Stomatognathic Function and Occlusal Reconstruction, Graduate School
Tokushima University
Institute
Department

Funding Source
Organization Education, Culture, Sports, Science and Ministry of Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 徳島大学病院(徳島犬)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027041

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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