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

Inogen Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nocturnal Hypoxemia

Interventions

InogenOne Rove 6 Portable Oxygen ConcentratorDEVICE

overnight use of Portable Oxygen Concentrator, 6 hours minimum

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Piedmont Healthcare

Statesville, North Carolina, United States

Outcomes

Primary Outcomes

Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time

oxygen saturation (SpO2)

Time frame: 6 hours overnight

Secondary Outcomes

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)

Time frame: 6 hours overnight

Time/% time above/below 90% target on initial setting and maximal setting

oxygen saturation (SpO2)

Time frame: 6 hours overnight

Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting

oxygen saturation (SpO2)

Time frame: 6 hours overnight

Minimum/maximum SpO2 on initial setting and maximal setting

oxygen saturation (SpO2)

Time frame: 6 hours overnight

Data from ClinicalTrials.gov

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