- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003702
Domiciliary Monitoring to Predict Exacerbations of COPD
October 10, 2018 updated by: University College, London
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, NW3 2PF
- Royal Free Hospital NHS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient diagnosed with COPD (smoking history of ≥10 pack years and FEV1/VC < 0.7 post-bronchodilator).
- Patient who had two or more self-reported moderate or severe COPD exacerbations in the past 12 months.
- Patient who can use study equipment and attend appointments.
- Can communicate in English.
Exclusion Criteria:
- Patient who was diagnosed with obstructive sleep apnea (through a self-report and/or a result of Stop Bang and Epworth questionnaires).
- Patient with co-morbidity preventing taking part.
- Patients already involved in an ongoing research study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ETH
Overnight monitoring
|
|
Other: CTH
Morning monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
December 22, 2016
First Posted (Estimate)
December 28, 2016
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 16/LO/1120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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