Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in quality of life
研究概览
简要总结
Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-
- •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-
- •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."
排除标准
- 未提供
研究组 & 干预措施
Normobaric Oxygen Therapy (40% FiO2)
4 weeks of nightly normobaric oxygen therapy (40% FiO2)
干预措施: Normobaric Oxygen (Device)
Placebo Condition
4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
干预措施: Placebo (Device)
结局指标
主要结局
Change from baseline in quality of life
时间窗: 4 weeks
Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.
Change from baseline in social functioning
时间窗: 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
时间窗: 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
时间窗: 4 weeks
Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).
Change from baseline in health-related quality of life
时间窗: 4 weeks
Change in scores on the RAND 36-Item Health Survey.
次要结局
- Change from baseline in substance use severity(4 weeks)
- Change from baseline in service utilization(4 weeks)
- Change in Sleep(4 weeks)
- Change from baseline in suicidality(4 weeks)
- Change from baseline in medication adherence(4 weeks)
研究者
Nicholas Breitborde
Principal Investigator
Ohio State University