Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Heart Rate (average of 1 minute)
研究概览
简要总结
Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.
These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.
详细描述
Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope.
POTS is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. These disabling symptoms persist for more than six months.
Objective The objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with POTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
- •an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120 bpm, and
- •chronic problems of symptoms during upright posture for at least 6 month.
- •Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.
- •The age limit is 18-75 years.
排除标准
- •Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known.
- •Pregnancy.
结局指标
主要结局
Heart Rate (average of 1 minute)
时间窗: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.
次要结局
- Orthostatic Tolerance (Maximal tolerated time in upright position)([0-50 min] relative time from tilt)
- Orthostatic Symptoms (Subjective analog symptoms scale (0-100)([-5,0,5,10,15,20,..,50 min] relative time from tilt)
研究者
Andre' Diedrich
Research Professor of Medicine
Vanderbilt University