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Domiciliary Monitoring to Predict Exacerbations of COPD

NCT03003702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-10-15

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in activities, patients are prone to developing chest infections called 'exacerbations'. Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore health facilities pressures) and death. Reducing the impact of exacerbations is very important. Investigators have previously shown that earlier treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital admission. Helping patients to detect exacerbations early is therefore important. Investigators have also recently shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this. However, measuring these variables when the patient is awake means they can be affected by other things, such as exercise and anxiety. Our new idea is that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD exacerbations early and our study will test that. Investigators will randomly allocate 77 patients with COPD recruited from our service in London to standard monitoring, or overnight monitoring, for up to six months or the first exacerbation, whichever is sooner. Investigators will then analyse whether overnight monitoring was able to detect exacerbations earlier, and therefore could be used to help patients get treatment earlier. A subset of participants will also wear an activity monitor overnight for the first two weeks, so that Investigators can assess the effect (if any) of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation recording.

Conditions

  • COPD Exacerbation

Interventions

DEVICE

Nonin

Sponsors & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003702 on ClinicalTrials.gov