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

Nocturnal Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000332
• Other study ID #: INO-05
• Status: Completed
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2024
• Source: Inogen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Nocturnal Hypoxemia

Intervention

Device:
• InogenOne Rove 6 Portable Oxygen Concentrator
overnight use of Portable Oxygen Concentrator, 6 hours minimum

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Statesville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Inogen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number/% of subjects that could achieve SpO2 =90% for >30% of sleep time	oxygen saturation (SpO2)	6 hours overnight
Secondary	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
Secondary	Time/% time above/below 90% target on initial setting and maximal setting	oxygen saturation (SpO2)	6 hours overnight
Secondary	Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting	oxygen saturation (SpO2)	6 hours overnight
Secondary	Minimum/maximum SpO2 on initial setting and maximal setting	oxygen saturation (SpO2)	6 hours overnight