UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	B-PAP Study
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
Scientific Title:Acronym	B-PAP Study
Region	Japan

Condition
Condition	Hypertensive patients with obstructive apnea (OSA)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A relationship between daily early morning blood pressure (systolic) and usage hours of CPAP in each night.
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	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)
Key exclusion criteria	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.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular, Medicine, Department of Medicine
Zip code
Address	3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satoshi Hoshide
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular, Medicine, Department of Medicine
Zip code
Address	3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL	0285-58-7344
Homepage URL
Email	hoshide@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Teijin Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	自治医科大学（栃木県）　鷲谷病院（栃木県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 28 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	2017 Year 06 Month 23 Day
Date of IRB	2017 Year 06 Month 23 Day
Anticipated trial start date	2017 Year 06 Month 29 Day
Last follow-up date	2019 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	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.

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2020 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032043