The ROAM Research Study Therapy (LTOT) Version
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Virginia
About this trial
The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. The display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Race demographics of the recruitment area reflect the population of the Charlottesville Metropolitan Statistical Area (MSA).
Due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit Hispanic participants to better match national percentages.
Participants with medical history of COPD
Subjects has to have a prescription for oxygen use via nasal cannula or mask at home
Disqualifiers
Intermittent oxygen use at home
Inability to understand simple instructions
No respiratory infections and exacerbation within 6 weeks of study
Trial population
100 COPD subjects with continuous oxygen wear
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
In lab validation study to confirm operation of the device
Repeatability and correlation of the device compared to standard clinical device (pulse ox and heart rate)
Time frame
2 hourSecondary outcomes
1
Overnight sleep lab testing while wearing the device to correlate the accuracy of the ROAM device using sleep study results.
Test the performance of the ROAM device overnight.
Time frame
Overnight ( 8-12 hours)2
Long-term ROAM device testing (4 weeks)
Testing the ROAM device in an ambulatory setting and follow-up after 2 weeks and return the device after 4 weeks.
Time frame
4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Barron Associates, Inc.
Collaborator
Source ClinicalTrials.gov