Internet-Behavioral Cough Suppression Therapy

Not Applicable

Completed

• Conditions: Cough; Chronic Disease
• Interventions: Behavioral: Sham Treatment; Behavioral: Internet-Behavioral Cough Suppression Therapy

• 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

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Study Start: 2023-07-01
• Status Verified: 2024-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham Treatment	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.
Internet-Behavioral Cough Suppression Therapy	Internet-Behavioral Cough Suppression Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Cough-Related Quality of Life	Baseline, pre-intervention, and immediately after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Hourly Cough Rate	Baseline, pre-intervention, and immediately after the intervention	Hourly cough frequency measured over one week.

Trial Locations

Locations (1)

University of Montana; 🇺🇸 Missoula, Montana, United States