← Back to Search

Other

Normobaric Oxygen Therapy for First-Episode Psychosis

N/A
Recruiting
Research Sponsored by Nicholas Breitborde
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
Ages 15-35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

This trial found that normobaric oxygen therapy had no effect on symptoms or cognition in people with first-episode psychosis.

Who is the study for?
This trial is for young adults aged 15-35 who have recently experienced their first episode of psychosis, specifically schizophrenia or mood disorders with psychotic features. Participants must be non-smokers without suicidal thoughts in the past month and have an IQ above 70.
What is being tested?
The study is testing if breathing normobaric oxygen can help with symptoms and thinking abilities in people with first-time psychosis. It's a single-blind trial where some get real oxygen therapy and others get a placebo, decided randomly.
What are the potential side effects?
While specific side effects are not listed, normobaric oxygen therapy is generally considered safe. However, potential side effects could include mild discomfort or nasal dryness from the oxygen delivery system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia or a mood disorder with psychosis.
Select...
I am between 15 and 35 years old.
Select...
I have been diagnosed with schizophrenia or a mood disorder with psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks 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 from baseline in cognitive functioning
Change from baseline in health-related quality of life
Change from baseline in quality of life
+2 more
Secondary study objectives
Change from baseline in medication adherence
Change from baseline in service utilization
Change from baseline in substance use severity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Normobaric Oxygen Therapy (40% FiO2)Experimental Treatment1 Intervention
4 weeks of nightly normobaric oxygen therapy (40% FiO2)
Group II: Placebo ConditionPlacebo Group1 Intervention
4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)

Find a Location

Who is running the clinical trial?

Nicholas BreitbordeLead Sponsor
1 Previous Clinical Trials

Media Library

Normobaric Oxygen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04368039 — N/A
Schizophrenia Research Study Groups: Placebo Condition, Normobaric Oxygen Therapy (40% FiO2)
Schizophrenia Clinical Trial 2023: Normobaric Oxygen Highlights & Side Effects. Trial Name: NCT04368039 — N/A
Normobaric Oxygen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368039 — N/A
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top