Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

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

Detailed Description
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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.

Official Title
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Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Conditions
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Psychosis, Schizophrenia, First-episode Psychosis

Intervention / Treatment
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* Device: Normobaric Oxygen
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normobaric Oxygen Therapy (40% FiO2)<br>4 weeks of nightly normobaric oxygen therapy (40% FiO2) | Device: Normobaric Oxygen<br>* 40% FiO2 for 4 weeks<br>|
| Placebo Comparator: Placebo Condition<br>4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2) | Device: Placebo<br>* 21% FiO2 for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cognitive functioning | Change in scores on the MATRICS Consensus Cognitive Battery (MCCB). | 4 weeks | 
| Change from baseline in quality of life | Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF. | 4 weeks | 
| Change from baseline in social functioning | Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning | 4 weeks | 
| Change from baseline in role functioning | Change in scores on the Global Functioning: Role Scale. Scores on this measure range from 1-10 with higher scores indicative of greater role functioning. | 4 weeks | 
| Change from baseline in health-related quality of life | Change in scores on the RAND 36-Item Health Survey. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in suicidality | Change in occurrence in suicidal thoughts or behaviors as assessed using the Columbia Suicide Severity Rating Scale. This is a categorical rating scale that identifies the presence or absence of specific levels of severity of suicidal ideation and behavior. | 4 weeks | 
| Change from baseline in substance use severity | Change in scores on the HABITS scale. This scale assesses the absolute values of use of specific substances (e.g., number of cigarettes smoked) | 4 weeks | 
| Change from baseline in service utilization | Change in scores on the Modified Service Use and Resources Form for Schizophrenia | 4 weeks | 
| Change in Sleep | Change in scores on the Pittsburgh Sleep Quality Index. | 4 weeks | 
| Change from baseline in medication adherence | Change in scores on the Medication Adherence rating Scale. Scores on this scale range from 0-10 with higher scores indicative of greater medication adherence. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosis, treatment, normobaric hyperoxia