Cough Management Wellness App for Refractory or Unexplained Chronic Cough
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorHyfe Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
≥10 consecutive pack-years smoking history within <10 years prior to screening.
Trial design
Design model
Single group
Treatments tested in this trial
Cough Management
BehavioralCoughPro 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
DeviceCoughMonitor 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cough ManagementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 4Secondary outcomes
1
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 42
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.3
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.Other outcomes
1
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 4.2
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. Source ClinicalTrials.gov