Internet-Behavioral Cough Suppression Therapy

NCT05770401 | Completed Results

• 1 other identifier: 163-22
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough; Chronic Disease

Keywords

refractory chronic cough; behavioral cough suppression therapy

Outcome Measures

Primary Outcomes (1)

• Leicester Cough Questionnaire

  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.

  Pre-treatment, one-week post-treatment, one-month post-treatment

Secondary Outcomes (1)

• Cough Severity Visual Analog Scale

  Pre-intervention, one-week post-treatment, one-month post-treatment

Study Arms (2)

Internet-Behavioral Cough Suppression Therapy

EXPERIMENTAL

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.

Behavioral: Internet-Behavioral Cough Suppression Therapy

Sham Treatment

SHAM COMPARATOR

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.

Behavioral: Sham Treatment

Interventions

Internet-Behavioral Cough Suppression Therapy BEHAVIORAL

Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.

Internet-Behavioral Cough Suppression Therapy

Sham Treatment BEHAVIORAL

Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Montana: lead

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

MeSH Terms

Conditions

Cough; Chronic Disease; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Jane Reynolds Salois
• Organization: University of Montana

jane.salois@umontana.edu

406-243-2138

Study Officials

• Jane Reynolds, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 15, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)