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Internet-Behavioral Cough Suppression Therapy

Primary Purpose

Cough, Chronic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Behavioral Cough Suppression Therapy
Sham Treatment
Sponsored by
University of Montana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring refractory chronic cough, behavioral cough suppression therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of MontanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Internet-Behavioral Cough Suppression Therapy

Sham Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Cough-Related Quality of Life
Cough-related quality of life will be measured with the Leicester Cough Questionnaire. This is a valid and reliable 19-item questionnaire measuring cough-related quality of life with a possible total score of 21 (a higher score indicates better quality of life). A change in 1.3 is considered clinically significant.

Secondary Outcome Measures

Hourly Cough Rate
Hourly cough frequency measured over one week.

Full Information

First Posted
February 1, 2023
Last Updated
October 12, 2023
Sponsor
University of Montana
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1. Study Identification

Unique Protocol Identification Number
NCT05770401
Brief Title
Internet-Behavioral Cough Suppression Therapy
Official Title
Internet-Behavioral Cough Suppression Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Montana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Chronic Disease
Keywords
refractory chronic cough, behavioral cough suppression therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-Behavioral Cough Suppression Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-Behavioral Cough Suppression Therapy
Intervention Description
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
Intervention Type
Behavioral
Intervention Name(s)
Sham Treatment
Intervention Description
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
Primary Outcome Measure Information:
Title
Change in Cough-Related Quality of Life
Description
Cough-related quality of life will be measured with the Leicester Cough Questionnaire. This is a valid and reliable 19-item questionnaire measuring cough-related quality of life with a possible total score of 21 (a higher score indicates better quality of life). A change in 1.3 is considered clinically significant.
Time Frame
Baseline, pre-intervention, and immediately after the intervention
Secondary Outcome Measure Information:
Title
Hourly Cough Rate
Description
Hourly cough frequency measured over one week.
Time Frame
Baseline, pre-intervention, and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Reynolds, PhD
Phone
406-243-2138
Email
jane.reynolds@mso.umt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Reynolds, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Reynolds, PhD
Phone
406-243-2138
Email
jane.reynolds@mso.umt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-Behavioral Cough Suppression Therapy

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