Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Visual Orientation and Executive Function
研究概览
简要总结
This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women ages 55 to 79 years old who have been diagnosed with MCI.
- •Must be willing to be assigned to either group: treatment or sham-treatment control.
- •Able to pay multiple visits to the lab for the proposed assessments.
- •Able to breathe moderately hypoxic air via an air-cushioned, disposable facemask.
- •To have controlled stabilized chronic conditions of at least 6 months duration, such as hypertension, coronary artery disease, diabetes or metabolic disease, chronic bronchitis, degenerative osteoporosis or arthritis and/or other aging-related chronic conditions.
- •Must be depression-free at the time of enrollment.
- •Must have arterial oxygen saturation at or above 95% and cerebral tissue oxygenation at or above 50% at rest.
- •Woman subject must be post-menopausal.
排除标准
- •Unwilling to sign a written consent to participate in this double-blinded placebo-controlled phase I trial.
- •Diagnosed with AD-dementia or have impaired independent daily functioning; with MMSE <20 and/or CDR ≥
- •Unable to visit the lab independently.
- •Claustrophobic to facemask and hyper-reactive to hypoxia exposure.
- •Expecting any major surgery or transplant.
- •Have un-controlled chronic conditions including systolic-diastolic pressures over 150/90 mmHg with medications, diabetes, chronic renal failure (based on the medical history questionnaire), obstructive sleep apnea (based on the medical history), recurrent chest pain, seizures or epilepsies, moderate to severe carotid stenosis or calcification, brain aneurysm, uncontrolled allergic rhinitis, pulmonary fibrosis, emphysema, cancer, infectious disease, atrial fibrillation, regular pre-mature ventricular contractions, myocardial ischemia or infarct, 2nd or 3rd degree atrio-ventricular blockade.
- •Have severe head injury or traumatic brain injury, stroke (hemorrhagic and/or ischemic).
- •Have currently diagnosed depression.
- •Currently have COVID-
- •Have any metallic implants or who are claustrophobic.
- •Currently participating in any interventional study and/or have been previously exposed to hypoxia, such as residing more than two months at altitudes above 5000 ft. within the past 3 years or previously participated in a hypoxia training study.
结局指标
主要结局
Visual Orientation and Executive Function
时间窗: Change from baseline 5-week, 8-week, and after up to 12-week intervention
Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function.
Overall Cognitive Function
时间窗: Change from baseline 5-week, 8-week, and up to 12-week intervention
Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function.
Attention and Short-term Memory
时间窗: Change from baseline 5-week, 8-week, and up to 12-week intervention
Change in scores or points in California-Verbal Learning Test - 2nd edition. Immediate Free-Recall (FR), short-delay FR and long-delay FR for words. More FR words indicate better testing performance and function.
Cognitive Function
时间窗: Change from baseline 5-week, 8-week, and up to 12-week intervention
Change in scores or points in Digit-Span test. Two different sets of Forward (from 3 to 9 digits) and Backward (from 2 to 8 digits) Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function.
次要结局
- Brain Morphology(before vs after up to 12-week intervention)
- Neurotoxic Protein(before vs after up to 12-week intervention)
- Cerebral Vascular Function(before vs after up to 12-week intervention)
- Neuroprotective Protein(before vs after up to 12-week intervention)
研究者
Xiangrong Shi
Associate Professor
University of North Texas Health Science Center