Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2025-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Refractory Chronic Cough Unexplained Chronic Cough Cough Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Single-Cohort Interventional Study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cough Management

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.

Group Type EXPERIMENTAL

Cough Management

Intervention Type 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).

CoughMonitor Suite

Intervention Type 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.

Interventions

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Cough Management

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).

Intervention Type BEHAVIORAL

CoughMonitor Suite

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.

Intervention Type DEVICE

Other Intervention Names

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Behavioural Cough Suppression Techniques (BCST) CoughPro Hyfe CoughMonitor Suite Hyfe CMS

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No