Internet-Behavioral Cough Suppression Therapy
- Conditions
- CoughChronic Disease
- Registration Number
- NCT05770401
- Lead Sponsor
- University of Montana
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Leicester Cough Questionnaire Pre-treatment, one-week post-treatment, one-month post-treatment Cough-related quality of life will be measured with the Leicester Cough Questionnaire (LCQ), a valid, reliable, and repeatable measure of cough-related quality of life. The LCQ is a 19-item questionnaire containing physical, psychological, and social domains. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). A higher score indicates better quality of life. A change in 1.3 is considered clinically significant. The LCQ total score was the primary outcome measure in this study.
- Secondary Outcome Measures
Name Time Method Cough Severity Visual Analog Scale Pre-intervention, one-week post-treatment, one-month post-treatment Cough Severity Visual Analog Scale (VAS) is a 100-millimeter line with anchors of 0 "no problem" and 100 "worst possible problem" where participants place a mark to represent the severity of their current cough problem. A reduction of at least 30-millimeters is considered clinically meaningful for the Cough Severity VAS.
Related Research Topics
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Trial Locations
- Locations (1)
University of Montana
🇺🇸Missoula, Montana, United States
University of Montana🇺🇸Missoula, Montana, United States