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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
IHT Treatment: IH exposure to 10% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks.
Sham-IHT Control: Exposure to 21% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks.
University of North Texas Health Science Center
Fort Worth, Texas, United States
RECRUITINGOverall Cognitive Function
Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function.
Time frame: Change from baseline 5-week, 8-week, and up to 12-week intervention
Attention and Short-term Memory
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.
Time frame: Change from baseline 5-week, 8-week, and up to 12-week intervention
Cognitive Function
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.
Time frame: Change from baseline 5-week, 8-week, and up to 12-week intervention
Visual Orientation and Executive Function
Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function.
Time frame: Change from baseline 5-week, 8-week, and after up to 12-week intervention
Neurotoxic Protein
Blood beta-amyloid assessed by enzyme-linked immunosorbent assay. Decreased concentrations indicate a better outcome.
Time frame: before vs after up to 12-week intervention
Neuroprotective Protein
Blood erythropoietin assessed by enzyme-linked immunosorbent assay. Increased concentrations indicate a better outcome.
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Time frame: before vs after up to 12-week intervention
Cerebral Vascular Function
Blood volume flow of carotid artery assessed by ultrasonography. Improved volume flow and vascular compliance in carotid arteries indicate a better outcome.
Time frame: before vs after up to 12-week intervention
Brain Morphology
Thickness of cortical gray matter assessed by brain MRI. Increased cerebral cortical gray matter indicates a better outcome.
Time frame: before vs after up to 12-week intervention