UMIN-CTR Clinical Trial

Basic information
Public title	Influences of tongue position controller on obstructive sleep apnea
Acronym	Tongue position and obstructive sleep apnea
Scientific Title	Influences of tongue position controller on obstructive sleep apnea
Scientific Title:Acronym	Tongue position and obstructive sleep apnea
Region	Japan

Condition
Condition	Adult patients diagnosed with obstructive sleep apnea by polysomnography
Classification by specialty	Medicine in general Pneumology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the hypothesis that obstructive sleep apnea could be alleviated if the tongue position is maintained through the use of a tongue position controller
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Apnea Hypopnea Index (AHI)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Tongue position controller
Interventions/Control_2	Mandibular advancement device
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	Adult patients with mild to moderate obstructive sleep apnea
Key exclusion criteria	Patients with insomnia, severe comorbidities, severe periodontitis, temporomandibular joint disorders
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name TSUIKI
Organization	Institute of Neuropsychiatry
Division name	Reserach Department
Zip code	162-0851
Address	91, Bentencho, Shinjuku, Tokyo
TEL	03-3944-2255
Email	strtsuiki@gmail.com

Public contact
Name of contact person	1st name Satoru Middle name Last name TSUIKI
Organization	Institute of Neuropsychiatry
Division name	Research Department
Zip code	162-0851
Address	91, Bentencho, Shinjuku, Tokyo
TEL	03-3944-2255
Homepage URL
Email	strtsuiki@gmail.com

Sponsor
Institute	Institute of Neuropsychiatry
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institute of Neuropsychiatry
Address	91, Bentencho, Shinjuku, Tokyo, Japan
Tel	03-3944-2255
Email	office.admin@ionp.or.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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 08 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	0
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	Terminated
Date of protocol fixation	2020 Year 09 Month 29 Day
Date of IRB	2020 Year 09 Month 29 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047987