SLP Model Development in the Diagnosis of COPD Patients (NCT04584801) | Clinical Trial Compass
CompletedNot Applicable
SLP Model Development in the Diagnosis of COPD Patients
United Kingdom201 participantsStarted 2021-05-05
Plain-language summary
This is an observational, comparative, multicentre study to develop a model for the Thora3Di™ against standard practice in patients who are undergoing investigation for COPD. The core methodology involves capturing of data during a short period of measurement of breathing using SLP against spirometric outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any adult (≥18 years old) who has been diagnosed with COPD guide GOLD criteria (FEV1/FVC ratio post bronchodilator \<0.70)
* Healthy Smokers (≥35 years old, current or ex-smoker with a history of ≥10 pack years (20 cigarettes smoked per day for 10 year))
Exclusion Criteria:
* Be unable to sit in an upright position for required period
* Have had deteriorated COPD symptoms since the last spirometry unless willing to undergo spirometry testing
* Have significant co-morbidities (i.e. Chest work or spinal deformity, OSA, AHI \>30 secs
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study
* Height \> 194 cm
* BMI \>40
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study
* Be unable to consent or comply with the study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To develop a machine learning model to use SLP data in patients diagnosed with COPD or healthy smokers to predict historical spirometry results (within 6 months) or prospective spirometry results, and classify subjects according to COPD/non-COPD.