Hyfe Inc.
Wilmington, Delaware, 19801, United States
Location status: Recruiting
NCT Number: NCT07070895
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Wilmington, Delaware, 19801, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Other names: 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.
Other names: Hyfe CoughMonitor Suite, Hyfe CMS
Time frame: 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.
Time frame: Fom baseline (week minus 1) to end of week 4
Change in cough intensity from baseline to end of Week 4, including:
Time frame: From baseline to 4 weeks after starting the intervention.
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 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 end of Week 4.
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: Interview on the study duration, done at the completion of 4 weeks on Cough Management intervention.
Usability interview evaluating the ease of use and features of the CoughPro app, following the completion of this study.
Contact information is provided by the study sponsor or research team.
Hyfe Inc
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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