Refractory Chronic CoughNCT07070895
Cough Management Wellness App for Refractory or Unexplained Chronic Cough
A study testing Cough Management and CoughMonitor Suite in people with Refractory Chronic Cough and Unexplained Chronic Cough, run by Hyfe Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Refractory Chronic Cough, Unexplained Chronic Cough, Cough Hypersensitivity
- What is being tested?
- Cough Management and CoughMonitor Suite
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hyfe Inc.
Wilmington, Delaware, 19801
Laurie Slovarp, PhD, CCC-SLP, 302-618-2348, study@hyfe.com
About this study
Official 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)
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:
Read more
- 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.
- Being tested
- Cough Management, CoughMonitor Suite
- 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
- Medical subject headings
- Chronic Cough, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough ManagementBehavioural
Also called Behavioural Cough Suppression Techniques (BCST), CoughPro
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).
CoughMonitor SuiteDevice
Also called Hyfe CoughMonitor Suite, Hyfe CMS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cough Management; Device: CoughMonitor Suite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (week minus 1) to end of Week 4
Secondary outcomes (3)
Change in cough intensity from baseline 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.
Measured: Fom baseline (week minus 1) to end of week 4
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.
Measured: From baseline to 4 weeks after starting the intervention.
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.
Measured: From baseline to 4 weeks after starting the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start27 Mar 2025
- Primary completion8 Aug 2025
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractory Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Single-Cohort Interventional Study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyfe Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070895
- Sponsor's protocol ID
- CPCoMg-001
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36550001Chaccour 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.
PubMed 39762316Yi 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.
PubMed 39707881Chamberlain 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.
PubMed 27682331Slovarp 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.
PubMed 33821355
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07070895
- Acronym / sponsor ID
- CPCoMg-001
- Keywords
- chronic cough, hyfe, cough monitoring, coughpro, refractory chronic cough, unexplained chronic cough, digital therapeutic, DTx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hyfe IncUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Single-Cohort Interventional Study
| Arm | Type | Receives |
|---|---|---|
| Cough Management | Experimental | Behavioral: Cough Management, Device: CoughMonitor SuiteCoughPro 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough ManagementAlso: Behavioural Cough Suppression Techniques (BCST), CoughProCoughPro 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). | Behavioural | Cough Management |
| CoughMonitor SuiteAlso: Hyfe CoughMonitor Suite, Hyfe CMSCoughMonitor 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. | Device | Cough Management |
Primary outcome
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.
3 secondary outcomes
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 subjective impression of cough burden
Time frame: From baseline to 4 weeks after starting the intervention.
Change in subjective impression of cough burden
Time frame: From baseline to 4 weeks after starting the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 36550001Sundholm 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.
- Background: PubMed 39762316Chaccour 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.
- Background: PubMed 39707881Yi 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.
- Background: PubMed 27682331Chamberlain 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.
- Background: PubMed 33821355Slovarp 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.
- Wellness app CoughPro used in this studyLink provided by the sponsor.
- Publications on Hyfe's cough monitoring technologyLink provided by the sponsor.
- CoughMonitor Suite's smartwatch used in this study for objective continuous cough monitoringLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Management and CoughMonitor Suite in people with Refractory Chronic Cough and Unexplained Chronic Cough, run by Hyfe Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Slovarp, PhD, CCC-SLP (302-618-2348, study@hyfe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective cough rate (coughs/hour) (time frame: From baseline (week minus 1) to end of Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07070895, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.