Clinical trial NCT06706765: Group Telehealth Behavioral Cough Suppression Therapy
Official title: Group Telehealth Behavioral Cough Suppression Therapy Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Refractory Chronic Cough
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Leicester Cough Questionnaire
timeFrame: Baseline, one-week post-treatment, and one-month post-treatment
Secondary outcomes:
measure: Patient Global Impression of Severity Scale in Chronic Cough
timeFrame: Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
References: