UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Non-randomized, single-center study for efficacy and safety of telemonitoring in the continuous positive airway pressure treatment for patient with newly diagnosed sleep apnea syndrome
Title of the study (Brief title)	Telemonitoring study of CPAP for SAS
Region	Japan

Condition
Condition	The patients who are newly diagnosed as sleep apnea syndrome and start continuous positive airway pressure treatment
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We apply clouded CPAP monitoring system for newly diagnosed sleep apnea syndrome and follow 3 months. The primary endpoint is average time of CPAP use on days used. Historical control is the previous data of the patients who were monitored by SD card.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Average time of CPAP use on days used 3 months after CPAP introduction.
Key secondary outcomes	1. Drop-out rate 2. The percentage of CPAP usage less than 4 hours 3. Average CPAP use on whole days 4. Residual AHI 5. Mask leak 6. Japanese Excessive sleepiness score 7. SF-36 8. Reason that stopped therapy 9.Travelling time to the hospital for patient 10. Time to follow up and care patient for doctors and co-medicals. 11. Time for care of patient for home care provider

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	ICT Group 60 samples. For ICT group, use of CPAP is monitored by cloud server on the 3rd,7th and 14th day after the start of therapy as well as after one and two months. Communication by telephone and mail, total work hours of healthcare professionals and employees of CPAP rental company are measured and recorded.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Outpatient only 2. Diagnosed as obstructive sleep apnea syndrome (OSAS) and has apnea-hypopnea Index (AHI) higher than 20 by polysomnography (PSG) 3. Direct contact is possible by telephone or e-mail 4. Patient who agreed to participate to this clinical study by written informed concent by his/her own free will after being well informed and understanding about this study.
Key exclusion criteria	Patients who meet one of the following criteria are excluded. 1. Patients with predominant central sleep apnea (CSA) 2. Patients with severe heart failure 3. Patient with severe respiratory failure 4. Patient with dementia 5. Patients with severe sleep disorder except SAS 6. Patients who some significant disease which influences CPAP therapy 7. Patients with claustrophobia 8. Patients who has past history of CPAP therapy. 9. Patients who want to be treated with oral appliance 10. Patients with significant nasal obstruction. 11. Occupational bus, truck, and taxi drivers who are screened by regular check-up, diagnosed as SAS, and introduced CPAP treatment. 12. Patient who sleeps without intending 13. Patients who cannot be contacted by telephone or e-mail regularly 14. Patients who participated in the other clinical study in last four months 15. Patients who are regularly visit our hospital with interval shorter than 3 months 16. Patients who are assessed as inadequate as the object of this clinical study by principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroyuki Yoshimine
Organization	Inoue Hospital
Division name	Internal Medicine
Address	6-12 Takara-machi, Nagasaki-city
TEL	095-844-1281
Email	yoshy@shunkaikai.jp

Public contact
Name of contact person	Hiroyuki Yoshimine
Organization	Inoue Hospital
Division name	Internal Medicine
Address	6-12 Takara-machi, Nagasaki-city
TEL	095-844-1281
Homepage URL
Email	yoshy@shunkaikai.jp

Sponsor
Institute	Inoue Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	ResMed Japan KK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Nagasaki University Yamax
Name of secondary funｄer(s)

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 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 08 Day
Anticipated trial start date	2016 Year 07 Month 26 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 25 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026868