UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023319 |
|---|---|
| Receipt number | R000026868 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2016/07/25 |
| Last modified on | 2016/07/25 11:33:41 |
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Basic information
Public title
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
Acronym
Telemonitoring study of CPAP for SAS
Scientific Title
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
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshimine |
Organization
Inoue Hospital
Division name
Internal Medicine
Zip code
Address
6-12 Takara-machi, Nagasaki-city
TEL
095-844-1281
yoshy@shunkaikai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshimine |
Organization
Inoue Hospital
Division name
Internal Medicine
Zip code
Address
6-12 Takara-machi, Nagasaki-city
TEL
095-844-1281
Homepage URL
yoshy@shunkaikai.jp
Sponsor or person
Institute
Inoue Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 06 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026868
