Internet-Behavioral Cough Suppression Therapy

University of Montana

Status: Completed

Conditions: Chronic Disease; Cough

Treatments: Behavioral: Sham Treatment; Behavioral: Internet-Behavioral Cough Suppression Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05770401

163-22

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Internet-Behavioral Cough Suppression Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-Behavioral Cough Suppression Therapy

Sham Treatment

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham Treatment