UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023118 |
|---|---|
| Receipt number | R000026623 |
| Scientific Title | Determination of face-to-face medical care intervals for continuous positive airway pressure therapy with remote monitoring system |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2019/10/19 15:53:31 |
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Basic information
Public title
Determination of face-to-face medical care intervals for continuous positive airway pressure therapy with remote monitoring system
Acronym
Determination of face-to-face medical care intervals for CPAP therapy with remote monitoring system
Scientific Title
Determination of face-to-face medical care intervals for continuous positive airway pressure therapy with remote monitoring system
Scientific Title:Acronym
Determination of face-to-face medical care intervals for CPAP therapy with remote monitoring system
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Cardiology | Pneumology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that it is possible to keep the treatment adherence for CPAP therapy by using the remote monitoring system while the face-to-face medical care intervals are extended.
Basic objectives2
Others
Basic objectives -Others
The non-inferiority of CPAP therapy using remote monitoring system to the conventional CPAP therapy is examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of days of CPAP usage with four or more hours per day during six month (The change in this rate between before and after the intervention will be evaluated. >5% decline will be defined as the adherence deterioration, and the number of patients with the deterioration will be examined.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention 1: During six months, we review the usage data of CPAP therapy (the rate of days of CPAP usage with four or more hours per day and the average apnea hypopnea index (AHI) per month) monthly by the remote monitoring system. We give the study subjects guidance through face-to-face medical cares every three months. At the months without face-to-face medical cares, we give the patients guidance through telemedicine only when the monthly rate of days of CPAP usage with four or more hours per day is less than 70%.
Interventions/Control_2
Intervention 2: During six months, we give the study subjects guidance through face-to-face medical cares every three months. At the times of face-to-face medical cares, we review the usage data of CPAP therapy (the rate of days of CPAP usage with four or more hours per day and the three-month average AHI) by the smartcard tracking system.
Interventions/Control_3
Control: During six months, we give the study subjects guidance through face-to-face medical cares every month. At the times of face-to-face medical cares, we review the usage data of CPAP therapy (the rate of days of CPAP usage with four or more hours per day and the monthly average AHI) by the smartcard tracking system.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We recruit outpatients having sleep apnea syndrome (SAS) diagnosed by polysomnography or unattended portable monitors and receiving CPAP therapy Patients can be included only when they have already received CPAP therapy and monthly or bimonthly face-to-face medical cares for three or more months at the outpatient setting and their SAS has been controlled at the monthly average AHI of 20 or less based on the remote monitoring or smartcard tracking data. At the time of enrollment, the usage data of CPAP therapy within the preceding three months through the remote monitoring or smartcard tracking system are necessary for randomization. Any remote monitoring system and any supplier and provider of the system are acceptable as far as the system can monitor the usage time of CPAP therapy per day and the average AHI per month and has started to work at the time of baseline (the start of study).
Key exclusion criteria
Patients are excluded when 1) they need to receive monthly or more frequent face-to-face medical cares for other reasons than CPAP therapy management from the same physicians, 2) they are receiving domiciliary oxygen therapy, 3) they have any active malignant neoplasm, 4) their cognitive functions are impaired enough to prevent them from completing the questionnaires or understanding the guidance through telemedicine or 5) they have been already scheduled for hospitalization during the study periods.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
6068385
Address
54 Shogoin-kawaracho, Sakyo-ku, Kyoto
TEL
075-751-3852
chin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiminobu |
| Middle name | |
| Last name | Tanizawa |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
6068385
Address
54 Shogoin-kawaracho, Sakyo-ku, Kyoto
TEL
075-751-3852
Homepage URL
enkaku@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate Scholl and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
54 Shogoinn Kawaharacho Sakyo Kyoto Japan
Tel
075-753-4683
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026623
