Trial Outcomes & Findings for Internet-Behavioral Cough Suppression Therapy (NCT NCT05770401)
NCT ID: NCT05770401
Last Updated: 2025-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Pre-treatment, one-week post-treatment, one-month post-treatment
Results posted on
2025-06-05
Participant Flow
Individuals with refractory chronic cough in the United States were recruited for the study via social media campaigns, newspaper advertisements, flyers sent to voice and upper airway clinics, word-of-mouth, and Facebook support groups. Recruitment took place from May 2023-2024.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
16
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Internet-Behavioral Cough Suppression Therapy
n=23 Participants
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.
|
Sham Treatment
n=16 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 Age
STANDARD_DEVIATION 9.4 • n=39 Participants • 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.
|
59.3 Age
STANDARD_DEVIATION 8.5 • n=41 Participants • 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.
|
60.5 Age
STANDARD_DEVIATION 9 • n=35 Participants • 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.
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants • 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.
|
13 Participants
n=41 Participants • 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.
|
34 Participants
n=35 Participants • 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.
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants • 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.
|
3 Participants
n=41 Participants • 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.
|
5 Participants
n=35 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=39 Participants • 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.
|
16 Participants
n=41 Participants • 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.
|
39 Participants
n=35 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants • 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.
|
1 Participants
n=41 Participants • 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.
|
1 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants • 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.
|
1 Participants
n=41 Participants • 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.
|
1 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
White
|
23 Participants
n=39 Participants • 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.
|
14 Participants
n=41 Participants • 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.
|
37 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants • 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.
|
0 Participants
n=41 Participants • 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.
|
0 Participants
n=35 Participants • 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.
|
PRIMARY outcome
Timeframe: Pre-treatment, one-week post-treatment, one-month post-treatmentPopulation: One participant in the IBCST group was lost to follow up at one-month post-treatment and values are missing.
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.
Outcome measures
| Measure |
Internet-Behavioral Cough Suppression Therapy
n=18 Participants
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.
|
Sham Treatment
n=12 Participants
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.
|
|---|---|---|
|
Leicester Cough Questionnaire
Pre-intervention
|
9.04 Total LCQ Score
Standard Deviation 7.32
|
8.86 Total LCQ Score
Standard Deviation 7.6
|
|
Leicester Cough Questionnaire
One-week post-treatment
|
12.78 Total LCQ Score
Standard Deviation 12.89
|
9.44 Total LCQ Score
Standard Deviation 12.27
|
|
Leicester Cough Questionnaire
one-month post-treatment
|
13.04 Total LCQ Score
Standard Deviation 4.31
|
9.70 Total LCQ Score
Standard Deviation 18.38
|
SECONDARY outcome
Timeframe: Pre-intervention, one-week post-treatment, one-month post-treatmentPopulation: One participant in the IBCST group was lost to follow up at one-month post-treatment and values are missing.
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.
Outcome measures
| Measure |
Internet-Behavioral Cough Suppression Therapy
n=18 Participants
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.
|
Sham Treatment
n=12 Participants
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.
|
|---|---|---|
|
Cough Severity Visual Analog Scale
Pre-intervention
|
49 VAS Total Score
Standard Deviation 15.97
|
49.08 VAS Total Score
Standard Deviation 22.39
|
|
Cough Severity Visual Analog Scale
One-week post-treatment
|
33.94 VAS Total Score
Standard Deviation 21.32
|
50.08 VAS Total Score
Standard Deviation 22.39
|
|
Cough Severity Visual Analog Scale
One-month post-treatment
|
44.18 VAS Total Score
Standard Deviation 22.85
|
56.42 VAS Total Score
Standard Deviation 23.74
|
Adverse Events
Internet-Behavioral Cough Suppression Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place