JPRN-jRCTs032210655招募中4 期
Randomized controlled trial of an oral appliance (SomnoDent) for sleep disordered breathing and cardiac function in patients with heart failure
Kasai Takatoshi0 个研究点目标入组 32 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Male or female >=20 years old
- •2) NYHA functional class >=II
- •3) Either HFrEF (LVEF <50%) or HFpEF (history of hospitalization for ADHF or plasma BNP level >=100 pg/mL or serum NT-proBNP level >=400 pg/mL)
- •4) Coexisting SDB (AHI of >=10 and percentage of central AHI per total AHI of <=70%)
- •5) Ability of attaching/detaching oral appliance
- •6) the use of beta blocker for more than 3 months and no change in medication within 2 weeks
- •7) the follow-up PSG is scheduled in registration
- •8) Craniofacial X-ray (cephalogram) and CT are scheduled in registration
排除标准
- •1) Insufficient teeth for splint retention
- •2) Evidence of active periodontal disease or dental caries
- •3) Change in HF drugs in 2 weeks
- •4)ACS (including STEMI, non-STEMI, and unstable angina)
- •5)Cardiac surgery (open heart surgery) within 3 months
- •6)Severe valvular heart disease
- •7) Life-threatening malignancy
- •8) COPD with oxygen inhalation
- •9) End-stage renal disease
- •10) Pregnancy
- •11) Occupational driver
研究者
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