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

Inogen

Status: Completed

Conditions: Nocturnal Hypoxemia

Treatments: Device: InogenOne Rove 6 Portable Oxygen Concentrator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06000332

INO-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

InogenOne Rove 6 Portable Oxygen Concentrator

Experimental group

Description:

InogenOne Rove 6 Portable Oxygen Concentrator

Treatment:

Device: InogenOne Rove 6 Portable Oxygen Concentrator