To Determine the Efficacy of Topical Cryotherapy on Supraglottic Laryngeal Mucosa in the Treatment of Chronic Neurogenic Cough in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pre and Post-time point differences.
研究概览
简要总结
This study aims to evaluate the safety and efficacy of upper aerodigestive tract cryotherapy treatment in patients with refractory neurogenic cough in a prospective pilot study with a validated patient reported outcome measure
详细描述
This study aims to test a new type of treatment for patients suffering from chronic cough, also known as upper airway cough syndrome. The new treatment involves the use of laryngeal cryotherapy which is the therapeutic freezing of tissue in the throat to numb the overactive sensory nerves in the throat which is believed to reduce cough symptoms. Patients will first undergo a flexible scope of the throat (laryngoscopy) to test for hypersensitive areas in the throat, then undergo the cryotherapy procedure in the office. After that, patients will be followed up in the clinic with the usual standard of care visits and undergo validated cough surveys to track their cough symptoms after the procedure. Possible side effects to this procedure are listed in detail below, and include temporary throat pain and coughing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 years or older with diagnosis of neurogenic cough
- •Neurogenic cough is a diagnosis of exclusion applied to persistent cough (8 weeks or longer)
- •Negative workup for other causes, including sinonasal allergies/chronic sinusitis, cough-variant asthma, and GERD
- •Patient willing to participate in a clinical trial
排除标准
- •Uncontrolled reflux (scoring on Reflux Symptom index of 13 or higher)
- •Vocal fold abnormalities or impairment
- •History of asthma or other underlying lung condition not adequately treated or controlled
- •Uncontrolled Allergic Rhinitis (Total Nasal Symptom Score >6, which would indicate moderate disease32)
- •Reported symptom of postnasal drip
- •Current smoker
- •Current neuromodulator medication use
- •Patient unwilling to participate in clinical trial or sign an informed consent
- •End stage medical disease with poor life expectancy
- •Medical instability deemed by the investigators as a contraindication for enrollment
- •Abnormal Chest X-ray
- •Abnormal pulmonary function testing (PFTs)
- •Positive local allergy panel (combined RAST testing)
研究组 & 干预措施
Upper airway cough syndrome
干预措施: Laryngeal cryotherapy (Procedure)
Upper airway cough syndrome
干预措施: Cryoprobe (Device)
结局指标
主要结局
Pre and Post-time point differences.
时间窗: 2 years
Sample size of 25 was determined based on expectations of a detectable significant within-group using a repeated measures ANOVA across 5 time points (add in the time points) with an alpha level of 0.0125, 85% power, and 1.246 effect size (based on previous work by Simpson et al PMID: 29668037.) needed to observe pre-post time point differences.
Improved quality of life of patients suffering from chronic cough
时间窗: 2 years
This is a validated patient reported outcome measure for chronic cough. This is a questionnaire of 10 questions about cough symptoms, each question is rated on a scale of 0-4 by the patient. The higher the CSI total score the worsen the cough symptoms are for the patient. The CSI will be compared across 5 time points (Pre-Laryngeal Cryotherapy, 1 week post cryotherapy, 1 month post cryotherapy, 3 months post cryotherapy and 6 months post cryotherapy) using repeated measures one-way ANOVA. Post-hoc pair-wise comparisons with Bonferroni correction will be used, as appropriate.
次要结局
- Pre- and post-treatment measures for the cryotherapy treatment group(2 years)
研究者
Shumon Dhar, MD
Assistant Professor
University of Texas Southwestern Medical Center