NCT05485129Unknown不适用
Use of HRV Measuring Hearing-aid Device to Detect Acute Stress
Hasselt University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Heart rate variability measured BIOMETRIC in-ear device
研究概览
简要总结
Validation of in-ear device to measure acute mental stress in comparison with a Polar H10 chest band. Stress is measured on the basis of heart rate variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dutch speaking and understanding
- •Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study
- •Age ≥ 50 years
- •No contra-indications for the use of the receiver in-the-ear device (BiometRIC SR 26UAA01GF), and smartwatch and chest strap heartrate monitor
排除标准
- •• Smokers
- •Obese patients (BMI >30 kg/m2)
- •Presence of a pacemaker
- •Supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole
- •Otologic contraindications determined by licensed otolaryngologist
结局指标
主要结局
Heart rate variability measured BIOMETRIC in-ear device
时间窗: 1 day
RMSSD
次要结局
未报告次要终点
研究者
prof. dr. Paul Dendale
Professor
Hasselt University
研究点 (2)
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