Effect of Behavioral Cough Suppression Therapy Delivered via Telehealth.
Nathaniel Sundholm, Sandeep Shelly, Miranda L Wright...
https://pubmed.ncbi.nlm.nih.gov/36550001Actively Recruiting
Phase Not Applicable
Age: 21Years +
All Genders
ID07070895
Effect of a Smartphone Cough Management Feature (CoughPro App) on Refractory or Unexplained Chronic Cough
Led by Hyfe Inc · Updated on 2025-09-11
20
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a smartphone-based Cough Management (CM) program designed to reduce cough frequency and burden in adults aged 21 to 80 years who have refractory or unexplained chronic cough. The study aims to determine if four weeks of using the CM feature in the CoughPro app can lower the objective cough rate compared to each participant's one-week baseline. It also investigates whether the program decreases cough intensity and improves quality of life based on patient-reported scores using the Leicester Cough Questionnaire and PGI-S. Participants will use the CoughPro wellness app, which includes behavioral lessons based on cough suppression therapy to help recognize and control the urge to cough. They will wear a Hyfe CoughMonitor smartwatch continuously for six weeks: one week for baseline cough monitoring, four weeks of the intervention using the CM program, and one week of follow-up. The smartwatch passively monitors cough frequency without recording audio. The program is delivered entirely through participants' devices. During the study, participants will complete online questionnaires at baseline and after four weeks of intervention. They will also take part in a brief exit interview before returning the smartwatch and receiving compensation. Researchers will measure changes in cough rate, cough intensity, and patient-reported cough burden. The total participation time is six weeks, including baseline, intervention, and follow-up periods.
CONDITIONS
Brief Title
Cough Management Wellness App for Refractory or Unexplained Chronic Cough
Who Can Participate
Age: 21Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 21 or older
- Currently have a cough lasting at least 8 weeks that is mostly dry (at least 50% of the time without mucus)
- Had a normal chest X-ray or chest CT scan specifically for the cough
- At least one physician visit for cough with standard treatment but inadequate relief
- Willing to avoid new cough treatments during the study or report changes
- Able and willing to wear the smartwatch daily and complete all questionnaires
- Understand and agree to the study procedures and compliance
You will not qualify if you...
- Recent upper respiratory infection within the past 4 weeks
- History of coughing up blood since current cough started
- Current smoker or vaping any substance
- Smoking history of 10 or more pack-years within less than 10 years before screening
- Diagnosed with chronic lung conditions such as COPD, emphysema, lung cancer, IPF, chronic bronchitis, or asthma (unless asthma is suspected but not diagnosed)
- Current or past head or neck cancer
- Difficulty swallowing
- Taking ACE inhibitor medications such as Benzapril, Captopril, Enalapril, Fosinopril, Lisinopril, Moexipril, Perindopril, Quinapril, Ramipril, or Trandolapril
- Prior speech-language pathologist treatment for cough
- Living with someone who frequently coughs interfering with monitoring
- Participation in another cough study within 30 days or 5 half-lives of that intervention
- Scheduled major surgery during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Outpatient Treatment
Duration - 4 weeks
Participants use the CoughPro smartphone application with a Cough Management feature delivering behavioral lessons to help manage cough. They also wear a smartwatch device that continuously monitors cough frequency.
Daily use of the smartphone app and smartwatch throughout the 4 weeks
Trial Site Locations
Total: 1 location
1
Hyfe Inc.
Wilmington, Delaware, United States, 19801
Actively Recruiting
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Research Team
L
Laurie Slovarp, PhD, CCC-SLP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study.
Carlos Chaccour, Isabel Sánchez-Olivieri, Sarah Siegel...
https://pubmed.ncbi.nlm.nih.gov/39762316Efficacy of behavioral cough suppression therapy for refractory chronic cough or unexplained chronic cough: a meta-analysis of randomized controlled trials.
Baiyi Yi, Shengyuan Wang, Xianghuai Xu...
https://pubmed.ncbi.nlm.nih.gov/39707881Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial.
Sarah A F Chamberlain Mitchell, Rachel Garrod, Lynne Clark...
https://pubmed.ncbi.nlm.nih.gov/27682331Evaluation and Management Outcomes and Burdens in Patients with Refractory Chronic Cough Referred for Behavioral Cough Suppression Therapy.
Laurie J Slovarp, Marie E Jetté, Amanda I Gillespie...
https://pubmed.ncbi.nlm.nih.gov/33821355