Recruiting

Normobaric Oxygen Therapy

Sponsor:

Nicholas Breitborde

Code:

NCT04368039

Conditions

Psychosis

Schizophrenia

First-episode Psychosis

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Not accepted

Interventions

Normobaric Oxygen

Placebo

Study Details

Brief summary:

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Conditions

Psychosis

Schizophrenia

First-episode Psychosis

Study ID

NCT04368039

Start date

Dec 4, 2019

Status verified date

Feb, 2026

Completion date

Dec 7, 2026

Anticipated

Primary completion date

Dec 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Not accepted

  • Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
  • Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .
  • No evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.
  • Ages 15-35
  • Non-smoker for past six months
  • Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale
  • The American Association for Respiratory Care notes that "no absolute contraindications to oxygen therapy exist when indications \[for oxygen therapy\] are present."

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Normobaric Oxygen Therapy (40% FiO2)

4 weeks of nightly normobaric oxygen therapy (40% FiO2)

placebo comparator: Placebo Condition

4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)

Interventions

Normobaric Oxygen

40% FiO2 for 4 weeks

Placebo

21% FiO2 for 4 weeks

Primary outcome measure

  • Change from baseline in cognitive functioning [ Time Frame: 4 weeks ]
  • Change from baseline in quality of life [ Time Frame: 4 weeks ]
  • Change from baseline in social functioning [ Time Frame: 4 weeks ]
  • Change from baseline in role functioning [ Time Frame: 4 weeks ]
  • Change from baseline in health-related quality of life [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Nicholas Breitborde, PhD

(614) 685-6052nicholas.breitborde@osumc.edu

Locations

Harding Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Nicholas Breitborde, PhD

614-685-6052nicholas.breitborde@osumc.edu

More Information

Sponsor

Nicholas Breitborde

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • psychosis
  • treatment
  • normobaric hyperoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nicholas Breitborde on 2026-02-25.