跳至主要内容
临床试验/NCT00962728
NCT00962728进行中(未招募)不适用

Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome

Alfredo Gamboa2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Magnitude of orthostatic heart rate increase on upright posture

研究概览

简要总结

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.

详细描述

Chronic orthostatic intolerance, sometimes known as the postural tachycardia syndrome (POTS), is the most common disorder among patients seen at several centers specializing in diseases of the autonomic nervous system. It affects an estimated 500,000 people in the United States alone. POTS (excessive increase in heart rate [>30 min-1] on standing associated with orthostatic symptoms [including palpitation, chest pain syndrome, dyspnea on standing, mental clouding and difficulties with concentration], in the absence of orthostatic hypotension) can produce substantial disability among otherwise healthy people. Patients with POTS typically feel tired and run down. Many also report a myriad of symptoms that are hard to categorize, often involving fatigue. One study, from the Mayo Clinic, found that patients with POTS had a diminished quality of life when measured using a standard health status instrument (SF-36).

In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic tachycardia in patients with postural tachycardia syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
  • Increase in heart rate ≥ 30 beats/min with position change from supine to standing (10 minutes)
  • Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
  • Able and willing to provide informed consent

排除标准

  • Overt cause for postural tachycardia (such as acute dehydration)
  • Inability to give, or withdrawal of, informed consent
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol

结局指标

主要结局

Magnitude of orthostatic heart rate increase on upright posture

时间窗: 10 min

次要结局

  • Hemodynamic changes on upright posture(10 min)
  • Symptoms rating with upright posture(10 min)

研究者

发起方
Alfredo Gamboa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alfredo Gamboa

Research Assistant Professor of Medicine

Vanderbilt University Medical Center

研究点 (2)

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