Group Telehealth Behavioral Cough Suppression Therapy

Early Phase 1

Recruiting

• Conditions: Refractory Chronic Cough

• Registration Number: NCT06706765
• Lead Sponsor: University of Montana

Brief Summary

The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• At least 18 years old
• Predominantly dry cough for at least 8 weeks
• Evaluated and treated by at least one physician for cough
• Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results
• Access to a computer or tablet that includes a camera and able to use the device independently
• Reliable internet access
• Willing to agree to maintain confidentiality of personal information (including names) related to others in the study

Exclusion Criteria

• Under age 18
• Coughing up blood
• Current smoker of any substance
• History of smoking or 10 or more years
• Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
• Diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat).
• Complaints of swallowing difficulty
• Taking any of the following medications, which have a known side effect of cough: 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)
• Prior BCST treatment with an SLP or respiratory therapist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Leicester Cough Questionnaire	Baseline, one-week post-treatment, and one-month post-treatment	The Leicester Cough Questionnaire is a 19-item self-report questionnaire that is valid and reliable, and repeatable every two weeks. The total possible score is 21. The higher the score the better the cough-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Severity Scale in Chronic Cough	Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment	The Patient Global Impression of Severity Scale in Chronic Cough involves the patient answering the question "how do you rate your overall current cough severity?" with options of "no problem, mild, moderate, or severe problem."

Trial Locations

Locations (1)

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