CoughNCT05770401
Internet-Behavioral Cough Suppression Therapy
A study testing Internet-Behavioral Cough Suppression Therapy in people with Cough and Chronic Disease, run by University of Montana at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, Chronic Disease
- What is being tested?
- Internet-Behavioral Cough Suppression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cough, Chronic Disease
- Being tested
- Internet-Behavioral Cough Suppression Therapy, Sham Treatment
- Keywords
- refractory chronic cough, behavioral cough suppression therapy
- Medical subject headings
- Cough, Chronic Disease, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Behavioral Cough Suppression TherapyBehavioural
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
Sham TreatmentBehavioural
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment, one-week post-treatment, one-month post-treatment
Secondary outcomes (1)
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.
Measured: Pre-intervention, one-week post-treatment, one-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Reynolds, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770401
- Sponsor's protocol ID
- 163-22
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2023
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Behavioral Cough Suppression Therapy
- ClinicalTrials.gov ID
- NCT05770401
- Acronym / sponsor ID
- 163-22
- Conditions
- Cough, Chronic Disease
- Keywords
- refractory chronic cough, behavioral cough suppression therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-Behavioral Cough Suppression Therapy | Experimental | Behavioral: Internet-Behavioral Cough Suppression TherapyParticipants 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. |
| Sham Treatment | Sham comparator | Behavioral: Sham TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Behavioral Cough Suppression TherapyParticipants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period. | Behavioural | Internet-Behavioral Cough Suppression Therapy |
| Sham TreatmentParticipants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period. | Behavioural | Sham Treatment |
Primary outcome
Leicester Cough Questionnaire
Time frame: Pre-treatment, one-week post-treatment, one-month post-treatment
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.
1 secondary outcome
Cough Severity Visual Analog Scale
Time frame: Pre-intervention, one-week post-treatment, one-month post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Reynolds, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Behavioral Cough Suppression Therapy in people with Cough and Chronic Disease, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leicester Cough Questionnaire (time frame: Pre-treatment, one-week post-treatment, one-month post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.