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

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.

Study Overview

• Status: Completed
• Conditions: Nocturnal Hypoxemia
• Intervention / Treatment: Device: InogenOne Rove 6 Portable Oxygen Concentrator

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Statesville, North Carolina, United States, 28625
      • Piedmont HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InogenOne Rove 6 Portable Oxygen Concentrator	Device: InogenOne Rove 6 Portable Oxygen Concentrator; overnight use of Portable Oxygen Concentrator, 6 hours minimum

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inogen Inc.
• Investigators: Study Chair: Stanislav Glezer, MD, Inogen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hypoxemia, oxygen
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: INO-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes