A Prospective Decentralized Investigation of the Effect of a Cough Management Feature Inside a Wellness Application (CoughPro) in Refractory or Unexplained Chronic Cough (RCC/UCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hyfe Inc
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in objective cough rate (coughs/hour)
研究概览
简要总结
The goal of this single-cohort clinical trial is to learn whether a smartphone-based Cough Management (CM) program can reduce cough frequency and burden in adults (21-80 years) who have refractory or unexplained chronic cough. 
The main questions it aims to answer are:
- Does four weeks of using the CM feature in the CoughPro app lower objective cough rate (coughs per hour) compared with each participant's one-week baseline? 
- Does the program also lessen cough intensity (bout metrics) and improve patient-reported quality-of-life scores on the Leicester Cough Questionnaire and PGI-S?
Participants will:
- Wear a Hyfe CoughMonitor smartwatch continuously for 6 weeks (1-week baseline, 4-week intervention, 1-week follow-up), charging it nightly. 
- Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week intervention.
- Fill out online questionnaires (LCQ and PGI-S) at baseline and at the end of Week 4.
- Join a brief exit interview, then return the smartwatch and receive a compensation voucher.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older.
- •Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed).
- •Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough.
- •At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief.
- •Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.
- •Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires.
- •Informed consent: understanding of the study procedures and agreement to comply with protocol.
排除标准
- •Recent upper respiratory infection (past 4 weeks).
- •History of hemoptysis (coughing up blood) since onset of the current cough.
- •Current smoker (incl. vaping) of any substance.
- •≥10 consecutive pack-years smoking history within <10 years prior to screening.
- •Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
- •Current or past head/neck cancer.
- •Difficulty swallowing.
- •On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
- •Prior treatment for cough by a speech-language pathologist.
- •Living with another individual with a frequent cough that would interfere with monitoring.
- •Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
- •Major scheduled surgery during the study period.
研究组 & 干预措施
Cough Management
CoughPro wellness application includes a Cough Management (CM) component, which delivers short, structured behavioral lessons (based on BCST) designed to help users recognize their urge to cough and apply cough suppression strategies in real-world settings. The Cough Management wellness feature is the key area of investigation in this study.
干预措施: Cough Management (Behavioral)
Cough Management
CoughPro wellness application includes a Cough Management (CM) component, which delivers short, structured behavioral lessons (based on BCST) designed to help users recognize their urge to cough and apply cough suppression strategies in real-world settings. The Cough Management wellness feature is the key area of investigation in this study.
干预措施: CoughMonitor Suite (Device)
结局指标
主要结局
Change in objective cough rate (coughs/hour)
时间窗: From baseline (week minus 1) to end of Week 4
Change in objective cough rate (coughs/hours) from baseline (week minus 1) to end of Week 4, measured by the CoughMonitor smartwatch.
次要结局
- Change in subjective impression of cough burden(From baseline to 4 weeks after starting the intervention.)
- Change in cough intensity from baseline to end of Week 4(Fom baseline (week minus 1) to end of week 4)