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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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).
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.
Hyfe Inc.
Wilmington, Delaware, United States
RECRUITINGChange 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.
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