An interventional study of Cough Management and CoughMonitor Suite in Refractory Chronic Cough, Unexplained Chronic Cough and Cough Hypersensitivity, sponsored by Hyfe Inc. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Hyfe Inc · Not applicable, Interventional, and Treatment
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:
Participants will:
142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 104 interventional studies indexed under Chronic Cough.
Browse Chronic Cough studies →Hyfe Inc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Cough Management · Device: CoughMonitor Suite
CoughPro is a smartphone wellness application that uses algorithms to detect and count coughs continuously and passively (similar to a "step counter," but for cough). CoughPro also 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. The novel CM program is delivered entirely through participants' devices. The application aims to help users better understand and manage their cough by coupling real-time cough detection with self-management BCST resources: * Reduce cough frequency (coughs per hour). * Reduce cough intensity (as measured by cough bouts). * Improve cough-related quality of life (as reported by patients and its correlation with cough-free time as measured objectively).
Also known as: Behavioural Cough Suppression Techniques (BCST), CoughPro
CoughMonitor Suite's smartwatch is used in this study to continuously, automatically, and passively monitor cough frequency in a fully privacy-preserving way - no audio is recorded, stored, or synced to the cloud, and no human is in the loop.
Also known as: Hyfe CoughMonitor Suite, Hyfe CMS
Change in objective cough rate (coughs/hour)
Change in objective cough rate (coughs/hours) from baseline (week minus 1) to end of Week 4, measured by the CoughMonitor smartwatch.
Time frame: From baseline (week minus 1) to end of Week 4
Change in cough intensity from baseline to end of Week 4
Change in cough intensity from baseline to end of Week 4, including: 1. Number of cough bouts per day. 2. Mean number of coughs within bouts.
Time frame: Fom baseline (week minus 1) to end of week 4
Change in subjective impression of cough burden
Change in subjective impression of cough burden using the Leicester Cough Questionnaire (LCQ) from baseline to 4 weeks after starting the intervention. LCQ covers the following domains (19 questions total, each with a value from 0 to 7): Physical, Psychological, Social. Domain scores are a total score from items in domain/number of items in domain (range 1-7). Total LCQ score results from the addition of domain scores with higher scores meaning a better outcome.
Time frame: From baseline to 4 weeks after starting the intervention.
Change in subjective impression of cough burden
Change in subjective impression of cough burden using the Patient Global Impression of Severity Scale in Chronic Cough (PGI-S) from baseline to 4 weeks after starting the intervention. Scale from 0 to 5, higher scores mean a worse outcome.
Time frame: From baseline to 4 weeks after starting the intervention.
Change in cough-free time
Change in cough-free time or intervals between coughs, statistical changepoint moments, and day/night distribution from baseline to end of Week 4.
Time frame: From baseline to end of Week 4.
Usability interview
Usability interview evaluating the ease of use and features of the CoughPro app, following the completion of this study.
Time frame: Interview on the study duration, done at the completion of 4 weeks on Cough Management intervention.
Plan to share: No
Ran from Mar 2025 to primary completion in Aug 2025, 4 months.
Of 20 interventional studies with no phase under Chronic Cough, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
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