UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023512 |
|---|---|
| Receipt number | 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 | 2022/02/08 19:29:13 |
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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 | Yoshizo |
| Middle name | |
| Last name | Matsuka |
Organization
Tokushima University
Division name
Department of Stomatognathic Function and Occlusal Reconstruction, Graduate Schoo
Zip code
771-8504
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
088-633-7350
matsuka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Okura |
Organization
Tokushima University
Division name
Department of Stomatognathic Function and Occlusal Reconstruction, Graduate Schoo
Zip code
770-8504
Address
3-18-15 kuramoto-cho Tokushima,Tokushima, japan
TEL
0886337350
Homepage URL
yosuzuki@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Stomatognathic Function and Occlusal Reconstruction, Graduate School
Tokushima University
Institute
Department
Personal name
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
Tokushima University
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
0886337350
yosuzuki@tokushima-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
徳島大学病院（徳島県）
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027041
| 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 |
