Back to resultsEvaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Primary Purpose
Nocturnal Hypoxemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InogenOne Rove 6 Portable Oxygen Concentrator
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Hypoxemia focused on measuring hypoxemia, oxygen
Eligibility Criteria
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, medroxyprogresterone, 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
Sites / Locations
- Piedmont HealthcareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
InogenOne Rove 6 Portable Oxygen Concentrator
Arm Description
InogenOne Rove 6 Portable Oxygen Concentrator
Outcomes
Primary Outcome Measures
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
oxygen saturation (SpO2)
Secondary Outcome Measures
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)
Time/% time above/below 90% target on initial setting and maximal setting
oxygen saturation (SpO2)
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
oxygen saturation (SpO2)
Minimum/maximum SpO2 on initial setting and maximal setting
oxygen saturation (SpO2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06000332
Brief Title
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Official Title
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2023 (Actual)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inogen Inc.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Hypoxemia
Keywords
hypoxemia, oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
InogenOne Rove 6 Portable Oxygen Concentrator
Arm Type
Experimental
Arm Description
InogenOne Rove 6 Portable Oxygen Concentrator
Intervention Type
Device
Intervention Name(s)
InogenOne Rove 6 Portable Oxygen Concentrator
Intervention Description
overnight use of Portable Oxygen Concentrator, 6 hours minimum
Primary Outcome Measure Information:
Title
Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
Description
oxygen saturation (SpO2)
Time Frame
6 hours overnight
Secondary Outcome Measure Information:
Title
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
Description
oxygen saturation (SpO2)
Time Frame
6 hours overnight
Title
Time/% time above/below 90% target on initial setting and maximal setting
Description
oxygen saturation (SpO2)
Time Frame
6 hours overnight
Title
Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
Description
oxygen saturation (SpO2)
Time Frame
6 hours overnight
Title
Minimum/maximum SpO2 on initial setting and maximal setting
Description
oxygen saturation (SpO2)
Time Frame
6 hours overnight
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, medroxyprogresterone, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Kamada, PharmD
Phone
984-309-9037
Email
akamada@inogen.net
First Name & Middle Initial & Last Name or Official Title & Degree
Stanislav Glezer, MD
Phone
609-454-7955
Email
stan.glezer@inogen.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislav Glezer, MD
Organizational Affiliation
Inogen Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Hutchens
Phone
704-924-2105
First Name & Middle Initial & Last Name & Degree
Joseph Moran, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
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