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Ambulatory ECG and Cough Monitoring in Chronic Cough Patients and Healthy Volunteers

COMPASS Phase II: A comparison of HRV measure by Ambulatory ECG and Cough Monitoring in Chronic Cough Patients and Healthy Volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12617335
Enrollment
60
Registered
2015-11-09
Start date
2015-09-30
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic idiopathic cough Respiratory Chronic idiopathic cough

Interventions

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

Sponsors

University Hospital of South Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

England, United Kingdom

Contacts

Public ContactRachel Dockry

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026