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Internet-Behavioral Cough Suppression Therapy

Not Applicable
Completed
Conditions
Cough
Chronic 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Leicester Cough QuestionnairePre-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
NameTimeMethod
Cough Severity Visual Analog ScalePre-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.

Trial Locations

Locations (1)

University of Montana

🇺🇸

Missoula, Montana, United States

University of Montana
🇺🇸Missoula, Montana, United States

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