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

NCT06000332 | Completed FDA Device

• 1 other identifier: INO-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Hypoxemia

Keywords

hypoxemia, oxygen

Outcome Measures

Primary Outcomes (1)

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

  oxygen saturation (SpO2)

  6 hours overnight

Secondary Outcomes (4)

• 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

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

  6 hours overnight

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

  6 hours overnight

• Minimum/maximum SpO2 on initial setting and maximal setting

  6 hours overnight

Study Arms (1)

InogenOne Rove 6 Portable Oxygen Concentrator

EXPERIMENTAL

InogenOne Rove 6 Portable Oxygen Concentrator

Device: InogenOne Rove 6 Portable Oxygen Concentrator

Interventions

InogenOne Rove 6 Portable Oxygen Concentrator DEVICE

overnight use of Portable Oxygen Concentrator, 6 hours minimum

InogenOne Rove 6 Portable Oxygen Concentrator

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, medroxyprogesterone, 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

Sponsors & Collaborators

• Inogen Inc.: lead

Study Sites (1)

Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanislav Glezer, MD

  Inogen Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 21, 2023
• Study Start: October 17, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)