Nocturnal Hypoxemia
Conditions
Keywords
hypoxemia, oxygen
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 the device can adequately maintain oxygen saturation during sleep.
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 oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve target with initial titration setting and/or with any needed adjustments of setting.
Interventions
DEVICEInogenOne Rove 6 Portable Oxygen Concentrator
overnight use of Portable Oxygen Concentrator, 6 hours minimum
Sponsors
Inogen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects may be of any gender 2. Subject's age must be 40 - 80 years 3. Subjects must have a current prescription for nocturnal oxygen \< 3 L/min continuous or current use of a Portable Oxygen Concentrator.
Exclusion criteria
1. 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). 2. Subjects with nasal obstruction 3. Subjects taking any drugs that affect respiratory center drive 4. Subject has an acute illness or hospitalization within the last 30 days 5. Subject has a change in medication within the last 15 days 6. Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone) 7. Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct 8. Subject's prescribed treatment is in conflict with study procedures 9. Subjects with any unstable disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time | 6 hours overnight | oxygen saturation (SpO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for >30% of sleep time criteria | 6 hours overnight | oxygen saturation (SpO2) |
| Time/% time above/below 90% target on initial setting and maximal setting | 6 hours overnight | oxygen saturation (SpO2) |
| Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting | 6 hours overnight | oxygen saturation (SpO2) |
| Minimum/maximum SpO2 on initial setting and maximal setting | 6 hours overnight | oxygen saturation (SpO2) |
Countries
United States
Outcome results
None listed