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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cough Management | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough Management | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (week minus 1) to end of Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cough intensity from baseline to end of Week 4 | Change in cough intensity from baseline to end of Week 4, including:
| Fom baseline (week minus 1) to end of week 4 |
| Change in subjective impression of cough burden |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to end of Week 4. |
| Usability interview |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurie Slovarp, PhD, CCC-SLP | Contact | 302-618-2348 | study@hyfe.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyfe Inc. | Recruiting | Wilmington | Delaware | 19801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36550001 | Background | Sundholm N, Shelly S, Wright ML, Reynolds J, Slovarp L, Gillespie AI. Effect of Behavioral Cough Suppression Therapy Delivered via Telehealth. J Voice. 2025 May;39(3):851.e1-851.e5. doi: 10.1016/j.jvoice.2022.11.015. Epub 2022 Dec 20. | |
| 39762316 | Background | Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3. |
| Label | URL |
|---|---|
| Wellness app CoughPro used in this study | View source |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Prospective, Single-Cohort Interventional Study
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| CoughMonitor Suite | Device | 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. |
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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. |
| 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. | From baseline to 4 weeks after starting the intervention. |
Usability interview evaluating the ease of use and features of the CoughPro app, following the completion of this study.
| Interview on the study duration, done at the completion of 4 weeks on Cough Management intervention. |
| 39707881 | Background | Yi B, Wang S, Xu X, Yu L. Efficacy of behavioral cough suppression therapy for refractory chronic cough or unexplained chronic cough: a meta-analysis of randomized controlled trials. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241305952. doi: 10.1177/17534666241305952. |
| 27682331 | Background | Chamberlain Mitchell SA, Garrod R, Clark L, Douiri A, Parker SM, Ellis J, Fowler SJ, Ludlow S, Hull JH, Chung KF, Lee KK, Bellas H, Pandyan A, Birring SS. Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial. Thorax. 2017 Feb;72(2):129-136. doi: 10.1136/thoraxjnl-2016-208843. Epub 2016 Sep 28. |
| 33821355 | Background | Slovarp LJ, Jette ME, Gillespie AI, Reynolds JE, Barkmeier-Kraemer JM. Evaluation and Management Outcomes and Burdens in Patients with Refractory Chronic Cough Referred for Behavioral Cough Suppression Therapy. Lung. 2021 Jun;199(3):263-271. doi: 10.1007/s00408-021-00442-w. Epub 2021 Apr 5. |
| Publications on Hyfe's cough monitoring technology | View source |
| CoughMonitor Suite's smartwatch used in this study for objective continuous cough monitoring | View source |
| D013568 | Pathological Conditions, Signs and Symptoms |