Treatment of Exertion Induced Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Dyspnea Index (DI) score pre and post therapy
研究概览
简要总结
Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction (VCD) is a laryngeal breathing disorder that has several potential causes. In some individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack, but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be devastating, leading to harmful, invasive, and ineffective treatments over a period of years. Numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly effective and even curative. However, data are lacking. The form of respiratory retraining technique tested in the current study educates people with PVFMD about breathing and teaches them a number of breathing exercises specially designed to restore normal breathing patterns.
This case series study will use a dyspnea perception questionnaire, patient daily logs, and physiological measurements of heart rate and breathing to examine whether this form of therapy can improve exertion-induced PVFMD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy according to available medical history or by patient and parent report on the health questionnaire
- •Patients with no history of asthma, or well-controlled asthma
- •A diagnosis of PVFMD by an otolaryngologist based on set criteria in-line with the National Jewish PVFMD diagnostics protocol (based on Hicks, 2008; Hoyte, 2013, Martin, 1987), to be confirmed by an additional otolaryngologist blinded to the initial diagnosis
- •A score of three or more on the dyspnea index (DI)
排除标准
- •A score of less than three on the DI
- •People diagnosed with hypertension, cardiac disorders or severe pulmonary diseases which affect blood oxygen saturation
- •Uncontrolled asthma
结局指标
主要结局
Change in Dyspnea Index (DI) score pre and post therapy
时间窗: measured at four points: day 1, day 21, day 42 and day 84
a 10-item symptom-based questionnaire validated on individuals with upper airway pathology, including PVFMD (Gartner-Schmidt, Shembel, Zullo, \& Rosen, 2014)
Change in the frequency and control of PVFMD patient-reported symptoms, pre and post therapy, measured by a daily log
时间窗: Measured daily for 84 days
The log will reflect participants' perceptions of frequency of PVFMD symptoms and their severity and ability to control them, using a three-item questionnaire using visual analogue scales (VAS) created by the investigators
次要结局
- ETCO2 using Capnometry(Measured on day 1, 21, 42 and 84)
- Heart rate using pulse oximetry and during home practice measured by the participants taking their pulse(Measured on day 1, 21, and then measured three times daily till day 84)
- Change in respiratory minute volume using Spirometry pre and post therapy(Measured on day 1, 21, 42 and 84)
- Control Pause (CP) or Steps(measured on day 1 and 21 and then measured three times daily till day 84)
研究者
Hadas Golan
CCC-SLP Hadas Golan
Boston Medical Center