Evaluating the Effects of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
- Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores?
- To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Veteran status
- •Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional.
- •The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently.
- •Exposed to at least one trauma-focused therapy or evidence-based psychotherapeutic treatment, such as prolonged exposure therapy, EMDR, or CBT, to name a few.
- •Completed cognitive and psychological measurements.
- •Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
- •Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session.
- •Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).
排除标准
- •Untreated pneumothorax
- •History of spontaneous pneumothorax
- •Severe sinus infection
- •Upper respiratory infection
- •Asymptomatic pulmonary lesions on chest x-ray
- •Uncontrollable high fever (greater than 39C)
- •History of chest or ear surgery
- •Congenital spherocytosis
- •Any anemia or blood disorder
- •Any convulsive disorder
- •History of optic neuritis or sudden blindness
- •Middle ear infection
- •Diabetes mellitus (insulin therapy)
- •The subject is pregnant or lactating
- •Nicotine use/substance use/addiction
- •Acute Hypoglycemia
- •Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
- •Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.
- •Active malignancy
- •Current manic, delusional, or psychotic episodes
- •Serious/current suicidal ideations
- •Severe or unstable physical disorders or major cognitive deficits
- •Inability to attend scheduled clinic visits or comply with study protocols.
- •Treated with HBOT for any reason prior to study enrollment.
- •Non-English speakers
- •History of retinal repair, including laser photocoagulation or retinal detachment surgery.
- •History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.
- •Age greater than 75 years.
- •Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapuetic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.
研究组 & 干预措施
HBOT Intervention Group
干预措施: Hyperbaric Oxygen Therapy (Drug)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to assess symptoms of PTSD
Generalized Anxiety Disorder 7-item scale (GAD-7)
时间窗: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to measure anxiety severity
NeuroTrax
时间窗: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.
A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to assess depression severity
World Health Organization Quality of Life (WHOQOL-BREF)
时间窗: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets
次要结局
未报告次要终点
研究者
Steve Wyman
Medical Director
Summit Hyperbarics and Wellness