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

Not Applicable

Completed

• Conditions: Nocturnal Hypoxemia
• Interventions: Device: InogenOne Rove 6 Portable Oxygen Concentrator

• Registration Number: NCT06000332
• Lead Sponsor: Inogen Inc.

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Study Start: 2023-10-17
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
InogenOne Rove 6 Portable Oxygen Concentrator	InogenOne Rove 6 Portable Oxygen Concentrator	InogenOne Rove 6 Portable Oxygen Concentrator

Primary Outcome Measures

Name	Time	Method
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time	6 hours overnight	oxygen saturation (SpO2)

Secondary Outcome Measures

Name	Time	Method
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)
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)
Time/% time above/below 90% target on initial setting and maximal setting	6 hours overnight	oxygen saturation (SpO2)

Trial Locations

Locations (1)

Piedmont Healthcare; 🇺🇸 Statesville, North Carolina, United States