Recruiting
Early Phase 1

Cough Suppression

Sponsor:

University of Montana

Code:

NCT06706765

Conditions

Refractory Chronic Cough

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Treatment

Study Details

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.

Conditions

Refractory Chronic Cough

Study ID

NCT06706765

Start date

Mar 22, 2024

Status verified date

Aug, 2024

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group Telehealth Behavioral Cough Suppression Therapy

Interventions

Behavioral Treatment

Behavioral cough suppression therapy delivered in a group setting via telehealth.

Primary outcome measure

  • Leicester Cough Questionnaire [ Time Frame: Baseline, one-week post-treatment, and one-month post-treatment ]

Central Contacts and Locations

Central contacts

Jane E Reynolds, PhD

406-243-2138jane.reynolds@mso.umt.edu

Laurie J Slovarp, PhD

406-243-2107laurie.slovarp@mso.umt.edu

Locations

University of Montana

Recruiting

Missoula, Montana, United States, 59812

Contacts

Jane E Reynolds, PhD

406-243-2138jane.reynolds@mso.umt.edu

Laurie J Slovarp, PhD

406-243-2107laurie.slovarp@mso.umt.edu

More Information

Sponsor

University of Montana

Last update posted

Nov 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Montana on 2024-11-27.