UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Chin Strap for Obstructive Sleep Apnea
Acronym	Efficacy of Chin Strap for OSA
Scientific Title	Efficacy of Chin Strap for Obstructive Sleep Apnea
Scientific Title:Acronym	Efficacy of Chin Strap for OSA
Region	Japan

Condition
Condition	Obstructive Sleep Apnea
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine whether a chin strap which is usually used in conjunction with CPAP is effective in treating OSA alone.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent reduction in AHI while using the chin strap compared to the AHI at diagnosis
Key secondary outcomes	Arousal index Oxygen desaturation index

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	Device,equipment
Interventions/Control_1	Use a chin strap to prevent the opening of the mouth.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing polysomnography for the diagnosis of OSA
Key exclusion criteria	Bilateral nasal obstruction Allergy to the material (rubber) of the chinstrap
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kasagi
Organization	Toranomon Hospital
Division name	Sleep Center
Zip code	105-8470
Address	Toranomon 2-2-2, Minato-ku, Tokyo
TEL	03-3588-1111
Email	s-kasagi@toranomon.gr.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Tomita
Organization	Toranomon Hospital
Division name	Sleep Center
Zip code	105-8470
Address	Toranomon 2-2-2, Minato-ku, Tokyo
TEL	03-3588-1111
Homepage URL
Email	ytomita.tmy@gmail.com

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The ethics committee of Toranomon Hospital
Address	Toranomon 2-2-2, Minato-ku, Tokyo
Tel	03-3588-1111
Email	chiken-jim@toranomon.gr.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	2021 Year 07 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	2021 Year 07 Month 16 Day
Date of IRB	2021 Year 07 Month 21 Day
Anticipated trial start date	2021 Year 09 Month 08 Day
Last follow-up date	2022 Year 12 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	2021 Year 07 Month 16 Day
Last modified on	2021 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051256