Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia

Conditions
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Nocturnal Hypoxemia

Intervention / Treatment
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* Device: InogenOne Rove 6 Portable Oxygen Concentrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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, medroxyprogresterone, 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InogenOne Rove 6 Portable Oxygen Concentrator<br>InogenOne Rove 6 Portable Oxygen Concentrator | Device: InogenOne Rove 6 Portable Oxygen Concentrator<br>* overnight use of Portable Oxygen Concentrator, 6 hours minimum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time | oxygen saturation (SpO2) | 6 hours overnight | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoxemia, oxygen