Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Hyfe

Status: Enrolling

Conditions: Unexplained Chronic Cough; Cough Hypersensitivity; Refractory Chronic Cough

Treatments: Behavioral: Cough Management; Device: CoughMonitor Suite

Study type: Interventional

Funder types: Other

Identifiers

NCT07070895

CPCoMg-001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cough Management

Experimental group

Description:

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.

Treatment:

Device: CoughMonitor Suite

Behavioral: Cough Management