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Oxygen Therapy
Portable Oxygen Therapy for Heart Failure
N/A
Waitlist Available
Research Sponsored by Inogen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9 minutes (3 minutes after the end of the 6mwt)
Awards & highlights
Study Summary
This trial looks at how well a portable oxygen device works in people with chronic heart failure, and how far they can walk.
Who is the study for?
This trial is for adults with stable chronic heart failure, ranging from NYHA class II to ambulatory IV. Participants must have an oxygen saturation of 96% or less at rest and be able to use a portable oxygen device without allergies to the cannula material. It's not for hospitalized patients, those with recent acute heart issues, inability to walk, or pregnant women.Check my eligibility
What is being tested?
The study tests whether using the Inogen Rove 6 Portable Oxygen Concentrator can improve walking distance during a Six Minute Walk Test in patients with chronic heart failure. This one-day pilot study aims to see if this device helps people walk farther without getting tired.See study design
What are the potential side effects?
While specific side effects are not listed for using a portable oxygen concentrator like the Inogen Rove 6, general potential side effects may include dry or bloody nose, fatigue, headaches and minor skin irritations from the cannula.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 9 minutes (3 minutes after the end of the 6mwt)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 minutes (3 minutes after the end of the 6mwt)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Modified Borg Scale
Oxygen saturation
+1 moreSecondary outcome measures
Adverse Events
Tolerance to POC
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: POC ONExperimental Treatment1 Intervention
6MWT with Inogen Rove 6 POC turned ON
Group II: POC OFFPlacebo Group1 Intervention
6MWT with Inogen Rove 6 POC turned OFF
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inogen Rove 6 Portable Oxygen Concentrator
2023
N/A
~20
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Who is running the clinical trial?
Inogen Inc.Lead Sponsor
3 Previous Clinical Trials
149 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a heart attack or unstable chest pain in the last 3 months.You cannot walk.You are an adult with chronic stable heart failure.You should not use the Point of Care (POC) device for a specific reason.You are currently experiencing severe heart failure and need extra medication to help your heart work better.You have heart problems that limit your physical activity.Your oxygen level at rest is 96% or lower when measured with a fingertip pulse oximeter.
Research Study Groups:
This trial has the following groups:- Group 1: POC ON
- Group 2: POC OFF
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators still receiving applicants for this experiment?
"As mentioned on clinicaltrials.gov, this trial is no longer accepting patients. It was initially posted on February 15th 2023 and the last update occurred 5 days later on February 5th 2023. Although this study has closed recruitment, 694 other trials are actively searching for participants at present."
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