Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Nicholas Breitborde

Status: Enrolling

Conditions: Schizophrenia; Psychosis; First-episode Psychosis

Treatments: Device: Normobaric Oxygen; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04368039

2019H0424

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Normobaric Oxygen Therapy (40% FiO2)

Experimental group

Description:

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

Treatment:

Device: Normobaric Oxygen

Placebo Condition

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo