NCT04368039

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nicholas Breitborde · Academic / Other
• Sex: All
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Functional deficits in prefrontal, limbic, and temporal regions of the brain are well-documented among individuals with psychotic disorders. Mitochondrial dysfunction may contribute to such pathology, and effective functioning of mitochondrial activity in the brain in dependent on a sufficient supply of oxygen. These data suggest that oxygen therapy may improve symptoms in individuals with psychosis. This small pilot study will test this hypothesis. Individuals with first-episode psychosis will be randomized to receive either (i) 4 weeks of nightly normobaric oxygen therapy (40% FiO2) or (ii) 4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2). Participants will be blinded to what condition they receive. Both conditions will be delivered via nasal cannula connected to oxygen concentrators at five liters per minute (lpm), and participants will be instructed to complete the intervention overnight while sleeping. At the end of the 4 week period, all individuals will receive an additional 4 weeks of unblinded (i.e., "open label") nightly normobaric oxygen therapy (40% FiO2). Study assessments will be completed at (i) enrollment; (ii) 4 weeks after enrollment, and (iii) 8 weeks after enrollment.

Conditions

• Psychosis
• Schizophrenia
• First-episode Psychosis

Interventions

Type	Name	Description
DEVICE	Normobaric Oxygen	40% FiO2 for 4 weeks
DEVICE	Placebo	21% FiO2 for 4 weeks

Timeline

• Start date: 2019-12-04
• Primary completion: 2026-12-07
• Completion: 2026-12-07
• First posted: 2020-04-29
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study