UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045198 |
|---|---|
| Receipt number | R000050672 |
| Scientific Title | To investigate the effect of a self-management tool for patients with obstructive sleep apnea initiating continuous positive airway pressure (CPAP) treatment |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/09/08 18:40:27 |
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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
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
ytomita.tmy@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050672
