UMIN-CTR Clinical Trial

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
Email	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
Email	yosuzuki@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	Tokushima University
Address	3-18-15 Kuramoto-cho, Tokushima
Tel	0886337350
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027041