Clinical trial NCT05770401: Internet-Behavioral Cough Suppression Therapy
Official title: Internet-Behavioral Cough Suppression Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Chronic Disease
Keywords: refractory chronic cough
behavioral cough suppression therapy
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Leicester Cough Questionnaire
timeFrame: Pre-treatment, one-week post-treatment, one-month post-treatment
Secondary outcomes:
measure: Cough Severity Visual Analog Scale
timeFrame: Pre-intervention, one-week post-treatment, one-month post-treatment
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
affiliation: Assistant Professor
name: Jane Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
References: