UMIN-ICDS Clinical Trial

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

Sleep apnea syndrome

Classification by specialty

Cardiology	Pneumology	Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000026623