Exploratory Endpoints in Respiratory Disorders
Research type
Research Study
Full title
Feasibility and Serial Change in Exploratory Endpoints (Parasternal EMG, Oscillometry, Actigraphy, Electrical Impedance Tomography, Home BP and Environmental Monitoring) in Patients with Respiratory Disorders
IRAS ID
226158
Contact name
Chris Carlin
Contact email
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Co-morbidities and patient capacity confound the performance of standard pulmonary function and exercise tests in respiratory disorders, and these tests are often insensitive to changes even with therapies/interventions of obvious benefit. It is plausible that new non-invasive investigation tools - surface intercostal parasternal electromyogram (EMG), portable airways oscillometry, electrical impedance tomography (EIT), wearable activity/heart rate variability monitors - will offer considerable benefits and provide novel physiological insights. Experience acquired so far indicates that these investigations will be applicable to a wider range of patients and more sensitive to changes with disease status and therapy. If appropriately benchmarked, these techniques should help rationalise respiratory condition treatment and other management decisions, and help establish new clinical trial endpoints.
In this study we propose to evaluate performing this panel of investigations - parasternal EMG, airways oscillometry, EIT, home BP and wristwatch/chest actigraphy - simultaneously in patients with selection of respiratory conditions at baseline and during follow up (from an exacerbation and/or after treatment) to determine the feasibility of performing this research investigation set simultaneously in this patient group, and obtain initial correlation/variance pilot data with the measurements derived from these investigations, for future endpoint validation studies.
Variations in air pollution exposure may account for variability in cardiorespiratory physiology, including the physiological variables that we plan to explore in this study. Clinical significance of this is uncertain but effects of air pollution on health are a public health priority. Accordingly we propose in this study to undertake home/personal air pollution monitoring, simultaneous with the other investigations, in a selected subgroup of patients. The aim again is to determine the feasibility of this air pollution monitoring, but the results will also provide initial data to help evaluate interplay between changes in respiratory disease status, changes in physiological measurements and air pollution exposure.
REC name
West of Scotland REC 3
REC reference
17/WS/0166
Date of REC Opinion
3 Aug 2017
REC opinion
Favourable Opinion