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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InogenOne Rove 6 Portable Oxygen Concentrator | Experimental | InogenOne Rove 6 Portable Oxygen Concentrator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InogenOne Rove 6 Portable Oxygen Concentrator | Device | overnight use of Portable Oxygen Concentrator, 6 hours minimum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time | oxygen saturation (SpO2) | 6 hours overnight |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | oxygen saturation (SpO2) | 6 hours overnight |
| Time/% time above/below 90% target on initial setting and maximal setting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislav Glezer, MD | Inogen Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2026 | Apr 9, 2026 | 3 |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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oxygen saturation (SpO2) |
| 6 hours overnight |
| Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting | oxygen saturation (SpO2) | 6 hours overnight |
| Minimum/maximum SpO2 on initial setting and maximal setting | oxygen saturation (SpO2) | 6 hours overnight |