AF-ASV
- Conditions
- Sleep disordered breathing (SDB),atrial fibrillation (AF)Apnea-hypopnea index (AHI) , LV diastolic function (E/e' ) , Sympathetic nerve activity (SNA)
- Registration Number
- JPRN-jRCTs032180344
- Lead Sponsor
- Kasai Takatoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
1)Adults (age of 20 or greater)
2)Patients with AF (paroxysmal, persistent, and permanent)
3)Moderate to severe SDB (i.e. AHI15-39 by home polygraphy test)
4) plasma BNP >40pg/mL or NT-proBNP >125pg/m
1)LV systolic dysfunction (LV ejection fraction less than or equal to 45% on echocardiogram)
2)Severe organic valvular diseases
3)Acute coronary syndrome within 3 months
4)Patients who underwent or planned for following treatments within 3 months from randomization: pacemaker; implantable cardiac defibrillator (ICD); cardiac resynchronization therapy (CRT); cardiac surgery; percutaneous coronary intervention (PCI); transcatheter aortic valve intervention (TAVI)
5)Life-threatening diseases (uncured malignancy, severe chronic pulmonary diseases with oxygen inhalation or specific medication, and end stage renal disease with dialysis)
6)Patients who received for PAP therapy within 2 weeks
7)Epworth sleepiness scale(ESS) greater than or equal to 11 or occupational driver
8)Pregnancy
9)Symptomatic OSA patients with class1 indication for PAP therapy in guidelines for diagnosis and treatment of acute and chronic heart failure (JCS 2017/JHFS 2017)
10)Patients eligible for CPAP initiation with reimbursement (AHI greater than or equal to 40)
11)Non-compliant patients (determined during tolerability test period, <70 % and <4 hrs/night will be non-compliant)
12)Non-suitable patients judged by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method