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
Qualifiers
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
Treatments tested in this trial
- Cough Management
- CoughMonitor Suite
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov