Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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 May 2021 (updated 02/10/2020, previously: June 2018.)

Who is funding the study?
University of Manchester (UK)

Who is the main contact?
Mrs Rachel Dockry

Trial website

Contact information



Primary contact

Mrs Rachel Dockry


Contact details

The Gregson Suite
North West Lung Research Centre
University Hospital of South Manchester
Southmoor Road
M23 9LT
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Case-control study

Trial setting


Trial type


Patient information sheet


Chronic idiopathic cough


Subjects wear both an ambulatory cough monitor and a Holter ECG monitor which will record simultaneously for 24 hours.

Intervention type



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester
North West Lung Research Centre Southmoor Road Wythenshawe
M23 9LT
United Kingdom

Sponsor information


University Hospital of South Manchester

Sponsor details

Research & Development Department
Southmoor Road
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

University of Manchester

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)


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


Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.