Status:
COMPLETED
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Lead Sponsor:
Inogen Inc.
Conditions:
Nocturnal Hypoxemia
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether t...
Detailed Description
The study design is a prospective, single site, single arm, open label, pilot study. The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxy...
Eligibility Criteria
Inclusion
- Subjects may be of any gender
- Subject's age must be 40 - 80 years
- Subjects must have a current prescription for nocturnal oxygen \< 3 L/min continuous or current use of a Portable Oxygen Concentrator.
Exclusion
- Subject is using any ancillary medical device(s) that may interfere with the operation of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).
- Subjects with nasal obstruction
- Subjects taking any drugs that affect respiratory center drive
- Subject has an acute illness or hospitalization within the last 30 days
- Subject has a change in medication within the last 15 days
- Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)
- Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct
- Subject's prescribed treatment is in conflict with study procedures
- Subjects with any unstable disease
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06000332
Start Date
October 17 2023
End Date
December 21 2023
Last Update
January 5 2024
Active Locations (1)
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1
Piedmont Healthcare
Statesville, North Carolina, United States, 28625