UMIN-CTR Clinical Trial

Basic information
Public title	To investigate the effect of a self-management tool for patients with obstructive sleep apnea initiating continuous positive airway pressure (CPAP) treatment
Acronym	To investigate the effect of self-management tool for initiating CPAP treatment
Scientific Title	To investigate the effect of a self-management tool for patients with obstructive sleep apnea initiating continuous positive airway pressure (CPAP) treatment
Scientific Title:Acronym	To investigate the effect of self-management tool for initiating CPAP treatment
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 myAir(TM), a self-management app, leads to behavioral changes and improves CPAP adherence in patients with obstructive sleep apnea who initiate CPAP treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of CPAP usage of 4 hours or more should be 70% or more within three months.
Key secondary outcomes	Percentage of days used Average usage time Mask leakage Sleep Questionnaire Time to discontinuation of CPAP and so on

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	App-based coaching
Interventions/Control_2	No use of app-based coaching
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 who meet the indications for CPAP therapy in Japan according to the past sleep study. Patients who plan to initiate CPAP therapy for obstructive sleep apnea. and so on
Key exclusion criteria	Patients who are unable to access the website or receive e-mails using a computer or smart phone. Patients who are unable to make outpatient visits or telephone revisits at the prescribed intervals for 6 months. and so on
Target sample size	160

Research contact person
Name of lead principal investigator	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
Email	ytomita.tmy@gmail.com

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	ResMed Pty Ltd
Organization
Division
Category of Funding Organization	Outside Japan
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	The ethics committee of Toranomon Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 09 Month 06 Day
Anticipated trial start date	2021 Year 10 Month 01 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	2025 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 08 Month 19 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=R000050672