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NCT Number: NCT07070895

Cough Management Wellness App for Refractory or Unexplained Chronic Cough

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyfe Inc.

Wilmington, Delaware, 19801, United States

Location status: Recruiting

Location contact

Laurie Slovarp, PhD, CCC-SLP

CONTACT

[email protected]

302-618-2348

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.
  • Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires.
  • Informed consent: understanding of the study procedures and agreement to comply with protocol.

Exclusion criteria

  • 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.
  • Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
  • Current or past head/neck cancer.
  • Difficulty swallowing.
  • On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
  • Prior treatment for cough by a speech-language pathologist.
  • Living with another individual with a frequent cough that would interfere with monitoring.
  • Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
  • Major scheduled surgery during the study period.

Treatment and study plan

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:

  • 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).

Other names: Behavioural Cough Suppression Techniques (BCST), CoughPro

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.

Other names: Hyfe CoughMonitor Suite, Hyfe CMS

Primary outcomes

  1. Change in objective cough rate (coughs/hour)

    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.

Secondary outcomes

  1. Change in cough intensity from baseline to end of Week 4

    Time frame: Fom baseline (week minus 1) to end of week 4

    Change in cough intensity from baseline to end of Week 4, including:

    • Number of cough bouts per day.
    • Mean number of coughs within bouts.
  2. Change in subjective impression of cough burden

    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.

  3. Change in subjective impression of cough burden

    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.

Other outcomes

  1. Change in cough-free time

    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.

  2. Usability interview

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie Slovarp, PhD, CCC-SLP

CONTACT

[email protected]

302-618-2348

Sponsors and collaborators

Lead sponsor

Hyfe Inc

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Sep 11, 2025

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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