Internet-Behavioral Cough Suppression Therapy

Study Overview
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Brief Summary
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The goal of this randomized, placebo-controlled, clinical trial is to develop and test the efficacy of an Internet-based behavioral intervention for refractory chronic cough. The main questions it aims to answer are: What are the best recruitment pathways to find people living with refractory chronic cough in Montana? Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious? Do iBCST participants find it satisfactory? Is using Hyfe research app to monitor cough frequency feasible in rural areas? Participants will complete iBCST or a placebo treatment virtually. Some participants will take part in qualitative interviews and use Hyfe research app for ambulatory cough frequency monitoring.

Official Title
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Internet-Behavioral Cough Suppression Therapy

Conditions
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Cough, Chronic Disease

Intervention / Treatment
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* Behavioral: Internet-Behavioral Cough Suppression Therapy
* Behavioral: Sham Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems). Internet and e-mail access and the ability to use it. Suffering from a cough lasting at least eight weeks that is: Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period). Report of cough triggered by identifiable stimuli including and not limited to any combination of the following: cold air, talking, laughing, taking a deep breath, exercise, crumbly foods, strong smells or odors, fumes from paint or cleaning sprays. Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat. Self-report of receiving the following assessments for current cough symptoms with unremarkable results: Physical evaluation by at least one physician. Chest x-ray. Willingness to avoid other potential cough treatments during the course of the study (or alert study personnel if alternative treatment is implemented out of necessity). Exclusion Criteria: Current smoker of any substance. Diagnosis of any of the following: Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma) Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease) Head and neck cancer Self-report of difficulty swallowing since having chronic cough Use of the following medication: Angiotensin-converting enzyme inhibitor (ACE-I) in the past four weeks: 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). Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline. Individuals with dysphonia (abnormal voice; either self-reported or perceived by study personnel during enrollment interview) will be excluded unless they have had a normal laryngoscopy (endoscopic assessment of the larynx) by an otolaryngologist (ENT) within the past year specifically for their cough.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-Behavioral Cough Suppression Therapy<br>Participants will watch treatment-specific educational and training videos and perform the training exercises as recommended. There are a total of five videos ranging from 2-5 minutes in length. Participants will be asked to watch the videos at least once weekly. Daily training exercises will be discussed in the videos and should take no more than a few minutes to complete every day. All exercises are non-invasive and are not physically demanding. Each week participants will complete a progress check question that will take less than one minute to answer, indicating whether they are watching the videos and completing the exercises as recommended. | Behavioral: Internet-Behavioral Cough Suppression Therapy<br>* Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.<br>|
| Sham Comparator: Sham Treatment<br>Participants will watch sham treatment-specific educational and training videos and perform the training exercises as recommended. There are a total of five videos ranging from 2-5 minutes in length. Participants will be asked to watch the videos at least once weekly. Daily training exercises will be discussed in the videos and should take no more than a few minutes to complete every day. All exercises are non-invasive and are not physically demanding. Each week participants will complete a progress check question that will take less than one minute to answer, indicating whether they are watching the videos and completing the exercises as recommended. | Behavioral: Sham Treatment<br>* Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cough-Related Quality of Life | Cough-related quality of life will be measured with the Leicester Cough Questionnaire. This is a valid and reliable 19-item questionnaire measuring cough-related quality of life with a possible total score of 21 (a higher score indicates better quality of life). A change in 1.3 is considered clinically significant. | Baseline, pre-intervention, and immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hourly Cough Rate | Hourly cough frequency measured over one week. | Baseline, pre-intervention, and immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory chronic cough, behavioral cough suppression therapy