Internet-Behavioral Cough Suppression Therapy | NCT05770401

NCT05770401

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Internet-Behavioral Cough Suppression Therapy	Experimental	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.	Behavioral: Internet-Behavioral Cough Suppression Therapy
Sham Treatment	Sham Comparator	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.	Behavioral: Sham Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet-Behavioral Cough Suppression Therapy	Behavioral	Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leicester Cough Questionnaire	Cough-related quality of life will be measured with the Leicester Cough Questionnaire (LCQ), a valid, reliable, and repeatable measure of cough-related quality of life. The LCQ is a 19-item questionnaire containing physical, psychological, and social domains. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). A higher score indicates better quality of life. A change in 1.3 is considered clinically significant. The LCQ total score was the primary outcome measure in this study.	Pre-treatment, one-week post-treatment, one-month post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Cough Severity Visual Analog Scale	Cough Severity Visual Analog Scale (VAS) is a 100-millimeter line with anchors of 0 "no problem" and 100 "worst possible problem" where participants place a mark to represent the severity of their current cough problem. A reduction of at least 30-millimeters is considered clinically meaningful for the Cough Severity VAS.	Pre-intervention, one-week post-treatment, one-month post-treatment

Eligibility Module

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.

Name	Affiliation	Role
Jane Reynolds, PhD	Assistant Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Montana		Missoula	Montana	59812	United States

Arm/Group Information

ID	Title	Description
FG000	Internet-Behavioral Cough Suppression Therapy	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.
FG001	Sham Treatment	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Internet-Behavioral Cough Suppression Therapy	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		Five IBCST participants and four control participants did not complete the intervention and no post-treatment data was collected from them so they are not included in any analyses.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Leicester Cough Questionnaire

Cough-related quality of life will be measured with the Leicester Cough Questionnaire (LCQ), a valid, reliable, and repeatable measure of cough-related quality of life. The LCQ is a 19-item questionnaire containing physical, psychological, and social domains. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). A higher score indicates better quality of life. A change in 1.3 is considered clinically significant. The LCQ total score was the primary outcome measure in this study.

One participant in the IBCST group was lost to follow up at one-month post-treatment and values are missing.

Posted

Mean

Standard Deviation

Total LCQ Score

Pre-treatment, one-week post-treatment, one-month post-treatment

ID	Title	Description
OG000	Internet-Behavioral Cough Suppression Therapy

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Internet-Behavioral Cough Suppression Therapy	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.

Title	Organization	Phone	Extension	Email
Jane Reynolds Salois	University of Montana	406-243-2138		jane.salois@umontana.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 7, 2025	Apr 7, 2025	Prot_SAP_000.pdf

ID	Term
D003371	Cough
D002908	Chronic Disease
D000096822	Chronic Cough

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

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.