Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
- Conditions
- First-episode PsychosisPsychosisSchizophrenia
- Interventions
- Device: Normobaric OxygenDevice: Placebo
- Registration Number
- NCT04368039
- Lead Sponsor
- Nicholas Breitborde
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normobaric Oxygen Therapy (40% FiO2) Normobaric Oxygen 4 weeks of nightly normobaric oxygen therapy (40% FiO2) Placebo Condition Placebo 4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
- Primary Outcome Measures
Name Time Method Change from baseline in quality of life 4 weeks Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.
Change from baseline in social functioning 4 weeks Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning
Change from baseline in role functioning 4 weeks 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.
Change from baseline in cognitive functioning 4 weeks Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).
Change from baseline in health-related quality of life 4 weeks Change in scores on the RAND 36-Item Health Survey.
- Secondary Outcome Measures
Name Time Method Change from baseline in substance use severity 4 weeks Change in scores on the HABITS scale. This scale assesses the absolute values of use of specific substances (e.g., number of cigarettes smoked)
Change from baseline in service utilization 4 weeks Change in scores on the Modified Service Use and Resources Form for Schizophrenia
Change in Sleep 4 weeks Change in scores on the Pittsburgh Sleep Quality Index.
Change from baseline in suicidality 4 weeks 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.
Change from baseline in medication adherence 4 weeks 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.
Trial Locations
- Locations (1)
Harding Hospital
🇺🇸Columbus, Ohio, United States