Clinical trial NCT06000332: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Hypoxemia
Keywords: hypoxemia, oxygen
Lead sponsor: Inogen Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time
timeFrame: 6 hours overnight
Secondary outcomes:
measure: 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
timeFrame: 6 hours overnight
measure: Time/% time above/below 90% target on initial setting and maximal setting
timeFrame: 6 hours overnight
measure: Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting
timeFrame: 6 hours overnight
measure: Minimum/maximum SpO2 on initial setting and maximal setting
timeFrame: 6 hours overnight
Other outcomes:
Locations:
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
Study officials:
affiliation: Inogen Inc.
name: Stanislav Glezer, MD
role: STUDY_CHAIR
References: