Unique ID issued by UMIN | UMIN000027981 |
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Receipt number | R000032043 |
Scientific Title | A prospective observational study to examine relationships between blood pressure variability and adherence to continuous positive airway pressure therapy in patients with hypertension and obstructive sleep apnea |
Date of disclosure of the study information | 2017/06/28 |
Last modified on | 2020/08/25 11:16:25 |
A prospective observational study to examine relationships between blood pressure variability and adherence to continuous positive airway pressure therapy in patients with hypertension and obstructive sleep apnea
B-PAP Study
A prospective observational study to examine relationships between blood pressure variability and adherence to continuous positive airway pressure therapy in patients with hypertension and obstructive sleep apnea
B-PAP Study
Japan |
Hypertensive patients with obstructive apnea (OSA)
Cardiology |
Others
NO
To examine the influence of adherence to CPAP on home blood pressure in hypertensive patients with OSA, and it's secondary effects on organ damages.
Efficacy
Exploratory
A relationship between daily early morning blood pressure (systolic) and usage hours of CPAP in each night.
1.A relationship between daily early morning blood pressure (diastolic) and usage hours of CPAP in each night
2.A relationship between an average
/ variation of clinic blood pressure (systolic and diastolic) and an average / variation of usage hours of CPAP in this time period.
3.A relationship between the change of various indicators that can evaluate organ damages and an average usage hours of CPAP during the time period
4.Factors associated with the usage hours of CPAP
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients who satisfy all of the following criteria
1.Outpatients diagnosed with hypertension.
2.Patients who undergo overnight sleep polygraph test at the medical institution, with AHI > 20, and have obstructive apneas accounting for more than half of total number of apneas.
3.Patients who already begun or are scheduled to begin treatment with a designated CPAP therapy device (sleepmate 9 or 10).
4.Patients who are already using NemLink or are scheduled to use it.
5.Patients aged 20 years or more at
consent acquisition.
6.Patients who have got a written consent from himself/herself.
7.Patients who gave a consent to participate in the PREDICT study. (UMINID:UMIN000019871)
1.Patients within 3 months of the onset of acute coronary syndrome (ACS).
2.Patients who can not walk independently.
3.Patients with severe chronic respiratory failure or chronic obstructive pulmonary disease.
4.Patients with severe chronic heart failure or chronic heart disease.
5.Patients diagnosed with arrhythmia such as atrial fibrillation.
6.Patients with central nervous system disorders caused by a stroke, or injuries.
7.Dialysis patient.
8.Patients whose QOL is restricted due to malignant tumor or other diseases.
9.Patients diagnosed with dementia.
10.Patients without the ability of giving a consent or the patients who are doubted for having the ability.
11.Other patients who are judged as unsuitable for this study by the
Attending physician.
100
1st name | |
Middle name | |
Last name | Kazuomi Kario |
Jichi Medical University School of Medicine
Division of Cardiovascular, Medicine, Department of Medicine
3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
0285-58-7344
kkario@jichi.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Hoshide |
Jichi Medical University School of Medicine
Division of Cardiovascular, Medicine, Department of Medicine
3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
0285-58-7344
hoshide@jichi.ac.jp
Jichi Medical University School of Medicine
Teijin Pharma Corporation
Profit organization
NO
自治医科大学(栃木県) 鷲谷病院(栃木県)
2017 | Year | 06 | Month | 28 | Day |
Unpublished
Completed
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 06 | Month | 29 | Day |
2019 | Year | 04 | Month | 03 | Day |
This is a prospective cohort study.
Recruitment of Target :
Those who agree with the selection criteria for patients who visited facilities implemented from June to December 2017.
Tracking period : One year every month.
2017 | Year | 06 | Month | 28 | Day |
2020 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032043
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