Internet-Behavioral Cough Suppression Therapy

Chronic Disease Clinical Trial

Official title:

Internet-Behavioral Cough Suppression Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770401
• Other study ID #: 163-22
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 18, 2025

Study information

• Verified date: January 2024
• Source: University of Montana
• Contact: Jane Reynolds, PhD
• Phone: 406-243-2138
• Email: jane.reynolds[@]mso.umt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 18, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Cough

Intervention

Behavioral:
• Internet-Behavioral Cough Suppression Therapy
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
• Sham Treatment
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.

Locations

Country	Name	City	State
United States	University of Montana	Missoula	Montana

Sponsors (1)

Lead Sponsor	Collaborator
University of Montana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hourly Cough Rate	Hourly cough frequency measured over one week.	Baseline, pre-intervention, and immediately after the intervention