UMIN-ICDS Clinical Trial

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
Email	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
Email	enkaku@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026623