Ambulatory ECG and Cough Monitoring in Chronic Cough Patients and Healthy Volunteers
| ISRCTN | ISRCTN12617335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12617335 |
| IRAS number | 184831 |
| Secondary identifying numbers | 15/COM2/001, IRAS 184831 |
- Submission date
- 14/09/2015
- Registration date
- 09/11/2015
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The autonomic nervous system (ANS) is the part of the nervous system which controls automatic bodily functions, such as breathing and blood pressure. A chronic cough, also known as a persistent cough, is a cough that has lasted for more than 8 weeks. In many cases, it has been found that people suffering from chronic cough also have problems with high blood pressure (hypertension). A possible reason for this could be that the ANS is not controlling bodily functions the way it should do. There may therefore be a link between coughing and other automatic functions such as the heart rate. Heart rate variability (HRV) is a measurement of the time between individual heart beats. As HRV is determined by the ANS, if there is a problem with the way the ANS is functioning then this could affect the HRV. The aim of this study is to investigate the link between coughing and HRV.
Who can participate?
Adults who took part in the COMPASS Phase I study (COMPASS 31 questionnaire) with a chronic cough and age matched healthy controls.
What does the study involve?
Participants who took part in phase 1 of the study (completing the COMPASS 31 questionnaire) and who wish to take part in phase 2, visit the hospital. There, any changes in medical history are checked using a short interview. Participants are then measured and weighed, and then attached to an ambulatory cough monitor and a Holter ECG monitor. These monitors remain in place for 24 hours, to continually collect information about the amount participants are coughing and their heart rate.
What are the possible benefits and risks of participating?
A possible benefit is that the participants are able to have a 24 hour ECG, which has the potential to detect any unknown heart conditions. There are no significant risks of participating, however skin irritation from the sticky pads attached to the monitors may be experienced in some people.
Where is the study run from?
University Hospital of South Manchester (UK)
When is the study starting and how long is it expected to run for?
August 2015 to June 2023
Who is funding the study?
University of Manchester (UK)
Who is the main contact?
Mrs Rachel Dockry
Contact information
Public
The Gregson Suite
North West Lung Research Centre
University Hospital of South Manchester
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Study information
| Study design | Single-centre case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | COMPASS Phase II: A comparison of HRV measure by Ambulatory ECG and Cough Monitoring in Chronic Cough Patients and Healthy Volunteers |
| Study acronym | COMPASS Phase II |
| Study objectives | Patients with chronic cough will exhibit abnormal heart rate variability (HRV). |
| Ethics approval(s) | NRES Committee North West, 04/09/2015, ref: 15/NW/0637 |
| Health condition(s) or problem(s) studied | Chronic idiopathic cough |
| Intervention | Subjects wear both an ambulatory cough monitor and a Holter ECG monitor which will record simultaneously for 24 hours. |
| Intervention type | Other |
| Primary outcome measure | Heart rate variability (HRV), calculated using the full 24 hour ECG trace recorded from the from the Holter device. A fast Fourier transform (FFT) method is used to investigate the changes in heart rate over the full day, to indicate autonomic activity. |
| Secondary outcome measures | 1. Cough count over 24 hours, recorded by the ambulatory cough monitor 2. Association between autonomic symptom score (COMPASS 31 questionnaire from part 1 of the study) and with cough counts and heart rate variability (HRV) |
| Overall study start date | 01/08/2015 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 - 40 chronic cough patient and 20 healthy volunteers |
| Key inclusion criteria | 1. Subjects who completed COMPASS Phase I and gave permission to be contacted by the research team regarding phase 2 2. Over 18 years of age 3. Cough subject only: Chronic cough, defined as a cough lasting longer than 8 weeks despite investigation and/or treatment trials for cough variant asthma, post-nasal drip and gastro-oesophageal reflux disease 4. No significant respiratory diseases (except chronic cough in the patient group) |
| Key exclusion criteria | 1. Recent upper respiratory tract infection (within 4 weeks) 2. Asthma; diabetic neuropathy; ischemic heart disease; fibromyalgia; previous brain injury; history of myocardial infarction or any other disorder deemed unsuitable by the investigator 3. Any neurological impairment which may have an effect on autonomic function and is deemed unsuitable by the investigator 4. Currently receiving ACE inhibitor treatment (e.g. lisinopril, perindopril, ramipril) 5. Currently on opiate cough suppressant treatment (e.g. codeine, morphine) 6. Current smoker or ex-smoker > 10 pack years still smoking within 6 months of study |
| Date of first enrolment | 30/09/2015 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Department
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom
| Website | http://www.researchdirectorate.org.uk/ |
|---|---|
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | This project forms part of a PhD and as such will be published within a thesis. We also hope to publish the results in a peer review journal. As a team, we publish a newsletter which is available for patients within our clinic and also mailed to volunteers who have expressed an interest in the results of the study in which they have participated. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date’. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/06/2024: The following changes were made:
1. IRAS number added.
2. The intention to publish date was changed from 30/06/2024 to 30/06/2025.
19/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2016 to 30/06/2023.
2. The overall end date was changed from 31/12/2022 to 30/06/2023.
3. The intention to publish date was changed from 31/05/2023 to 30/06/2024.
4. The plain English summary was updated to reflect these changes.
11/05/2022: The overall trial end date has been changed from 31/05/2022 to 31/12/2022 and the plain English summary has been updated accordingly.
08/12/2021: The IPD sharing statement has been added.
03/12/2021: The following changes have been made:
1. The overall trial end date has been changed from 31/05/2021 to 31/05/2022 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/05/2021 to 31/05/2023.
02/10/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/05/2020 to 31/05/2021.
2. The plain English summary was updated to reflect these changes.
20/06/2019: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2018 to 30/05/2020.
2. The intention to publish date was changed from 30/06/2017 to 30/05/2021.
18/12/2017: Overall trial end date was changed from 31/12/2017 to 30/06/2018.
09/03/2017: Overall trial end date was changed from 01/03/2016 to 31/12/2017.
