Plain English Summary
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 March 2016
Who is funding the study?
University of Manchester (UK)
Who is the main contact?
Mrs Rachel Dockry
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15/COM2/001
Study information
Scientific title
COMPASS Phase II: A comparison of HRV measure by Ambulatory ECG and Cough Monitoring in Chronic Cough Patients and Healthy Volunteers
Acronym
COMPASS Phase II
Study hypothesis
Patients with chronic cough will exhibit abnormal heart rate variability (HRV).
Ethics approval
NRES Committee North West, 04/09/2015, ref: 15/NW/0637
Study design
Single-centre case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/08/2015
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant 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)
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
20 - 40 chronic cough patient and 20 healthy volunteers
Participant 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
Recruitment start date
30/09/2015
Recruitment end date
30/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of South Manchester
North West Lung Research Centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
University Hospital of South Manchester
Sponsor details
Research & Development Department
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Manchester
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
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.
Intention to publish date
30/06/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary