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Oxygen Therapy

Supplemental Oxygen for Pulmonary Hypertension (SOPHIE Trial)

Phase 1 & 2
Waitlist Available
Led By Daniel Edmonston, MD, MHS
Research Sponsored by Duke University
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 weeks 1, 2, and 3

Summary

This trial aims to see if giving extra oxygen during dialysis can help people with high blood pressure in the lungs and low oxygen levels during dialysis.

Who is the study for?
This trial is for individuals who have pulmonary hypertension (high blood pressure in the lungs) and experience low oxygen levels during hemodialysis, a treatment for kidney failure. Specific eligibility details are not provided.
What is being tested?
The study is testing whether giving extra oxygen during hemodialysis can help people with lung-related high blood pressure compared to those breathing normal room air.
What are the potential side effects?
Potential side effects may include dry or bloody nose, morning headaches, tiredness, and irritation from the oxygen delivery system. However, specific side effects related to this trial's interventions are not detailed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change daily hypoxemia burden
Secondary study objectives
Change in Montreal Cognitive Assessment (MoCA)
Change in six minute walk distance

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Supplemental oxygen (3 liters per minute)Experimental Treatment1 Intervention
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Group II: Supplemental oxygen (0.5 liters per minute)Experimental Treatment1 Intervention
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
Group III: Room airPlacebo Group1 Intervention
Participants will receive no supplemental oxygen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen
2013
Completed Phase 4
~12210

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
2,971,749 Total Patients Enrolled
Daniel Edmonston, MD, MHSPrincipal InvestigatorDuke University
~7 spots leftby Jun 2026
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