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Chronic Obstructive Pulmonary Disease (COPD) Breathing Record Study

NCT02814253 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-06-02

No results posted yet for this study

Summary

This study is being done to collect information that will be used in the development of a new medical device. The new device is intended to help people with COPD to monitor their condition at home on a daily basis.

The device used in this study is called a capnometer. Different types of capnometer have been in use by doctors for many years. Capnometers measure the amount of carbon dioxide in your breath. The device that is used in this study is called the N Tidal C. It is a small, battery-powered personal device for you to use indoors either at home, at work or in hospital.

The study fits around the normal treatment, tests and medication of COPD patients and there will not be any changes made to the treatment of any study participants.

The study lasts for six weeks. Standard care clinical assessments will be taken at the start of the study, after 2 weeks, 4 weeks and 6 weeks. The tests for COPD include a check-up by the study doctor or nurse including the usual spirometry and blood gas tests. Each assessment visit will last for between 15-20 minutes.

At the start of the study each participant will be trained in the use of the device and they will be asked to use the device to record their normal relaxed breathing, 3 times a day (morning, afternoon and evening) every day for the 6- week period. A reading takes seventy-five seconds of ordinary breathing through the device.

Participants who feel unwell, or have an infection, will be asked to take more frequent breath records of up to six times a day if possible. This would be twice in the morning, twice in the afternoon and twice in the evening, leaving at least an hour between readings.

Participants will also be asked to complete a simple daily diary of how their health and COPD changes and information on the use of the device.

Participants will receive a telephone call 2 weeks after their last assessment visit to check how they are and to ask if any of their medicines have changed.

Participants will not benefit directly from taking part in this study and the device used in the study does not provide any feedback to them. The information we get from this study will help us to develop the device, and to learn more about the treatment and management of COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • TidalSense

    lead INDUSTRY

Principal Investigators

  • Ravi Mahadeva · Cambridge University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2016-07-06
Completion
2016-12-31

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 NCT02814253 on ClinicalTrials.gov