Cough Management Wellness App for Refractory or Unexplained Chronic Cough

NCT07070895 | Recruiting DMC

• 1 other identifier: CPCoMg-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Chronic Cough; Unexplained Chronic Cough; Cough Hypersensitivity

Keywords

chronic cough; hyfe; cough monitoring; coughpro; refractory chronic cough; unexplained chronic cough; digital therapeutic; DTx; software enhanced treatment; cough management; behavioural cough suppression techniques; BCST; digital health; CoughMonitor Suite; cough tracking; cough recording; cough bouts; coughing; cough hypersensitivity; urge to cough; cough-free time; Leicester Cough Questionnaire (LCQ)

Outcome Measures

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.

  From baseline (week minus 1) to end of Week 4

Secondary Outcomes (3)

• Change in cough intensity from baseline to end of Week 4

  Fom baseline (week minus 1) to end of week 4

• Change in subjective impression of cough burden

  From baseline to 4 weeks after starting the intervention.

• Change in subjective impression of cough burden

  From baseline to 4 weeks after starting the intervention.

Other Outcomes (2)

• Change in cough-free time

  From baseline to end of Week 4.

• Usability interview

  Interview on the study duration, done at the completion of 4 weeks on Cough Management intervention.

Study Arms (1)

Cough Management

EXPERIMENTAL

CoughPro wellness application 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.

Behavioral: Cough Management; Device: CoughMonitor Suite

Interventions

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).

Also known as: Behavioural Cough Suppression Techniques (BCST), CoughPro

Cough Management

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.

Also known as: Hyfe CoughMonitor Suite, Hyfe CMS

Cough Management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hyfe Inc: lead

Study Sites (1)

Hyfe Inc.

Wilmington, Delaware, 19801, United States

RECRUITING

Related Publications (5)

• Sundholm N, Shelly S, Wright ML, Reynolds J, Slovarp L, Gillespie AI. Effect of Behavioral Cough Suppression Therapy Delivered via Telehealth. J Voice. 2025 May;39(3):851.e1-851.e5. doi: 10.1016/j.jvoice.2022.11.015. Epub 2022 Dec 20.

  PMID: 36550001 BACKGROUND

• Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3.

  PMID: 39762316 BACKGROUND

• Yi B, Wang S, Xu X, Yu L. Efficacy of behavioral cough suppression therapy for refractory chronic cough or unexplained chronic cough: a meta-analysis of randomized controlled trials. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241305952. doi: 10.1177/17534666241305952.

  PMID: 39707881 BACKGROUND

• Chamberlain Mitchell SA, Garrod R, Clark L, Douiri A, Parker SM, Ellis J, Fowler SJ, Ludlow S, Hull JH, Chung KF, Lee KK, Bellas H, Pandyan A, Birring SS. Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial. Thorax. 2017 Feb;72(2):129-136. doi: 10.1136/thoraxjnl-2016-208843. Epub 2016 Sep 28.

  PMID: 27682331 BACKGROUND

• Slovarp LJ, Jette ME, Gillespie AI, Reynolds JE, Barkmeier-Kraemer JM. Evaluation and Management Outcomes and Burdens in Patients with Refractory Chronic Cough Referred for Behavioral Cough Suppression Therapy. Lung. 2021 Jun;199(3):263-271. doi: 10.1007/s00408-021-00442-w. Epub 2021 Apr 5.

  PMID: 33821355 BACKGROUND

Related Links

• Wellness app CoughPro used in this study
• Publications on Hyfe's cough monitoring technology
• CoughMonitor Suite's smartwatch used in this study for objective continuous cough monitoring

MeSH Terms

Conditions

Chronic Cough; Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laurie Slovarp, PhD, CCC-SLP

CONTACT

302-618-2348; study@hyfe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Single-Cohort Interventional Study

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 17, 2025
• Study Start: March 27, 2025
• Primary Completion: August 8, 2025
• Study Completion: September 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)