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โ† Trials
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Cough Management Wellness App for Refractory or Unexplained Chronic Cough

RecruitingNAAges 21 Years - anyAllHyfe Inc
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In plain words

What the trial is, and whether it could suit you

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. ๏ฟผ 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? ๏ฟผ * 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. ๏ฟผ * Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week inte

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * โ‰ฅ10 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.
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What it tests

  • Cough Management
  • CoughMonitor Suite
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Where

1 site
Hyfe Inc.
Wilmington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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