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Completed

NCT Number: NCT06000332

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.

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Key information

Conditions

Nocturnal Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Healthcare

Statesville, North Carolina, 28625, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

InogenOne Rove 6 Portable Oxygen Concentrator

Device

overnight use of Portable Oxygen Concentrator, 6 hours minimum

Primary outcomes

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

    Time frame: 6 hours overnight

    oxygen saturation (SpO2)

Secondary outcomes

  1. 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

    Time frame: 6 hours overnight

    oxygen saturation (SpO2)

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

    Time frame: 6 hours overnight

    oxygen saturation (SpO2)

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

    Time frame: 6 hours overnight

    oxygen saturation (SpO2)

  4. Minimum/maximum SpO2 on initial setting and maximal setting

    Time frame: 6 hours overnight

    oxygen saturation (SpO2)

Sponsors and collaborators

Lead sponsor

Inogen Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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