IHT for Mild Cognitive Impairment
Start Date
2/27/2023
Completion Date
4/30/2026
Summary
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).
Detailed Description
Volunteer subjects 55-79 years age will sign an informed consent and complete a medical history form. The number of recruited minority subjects will be targeted to approximate the ethnic/racial demographics of the general population in Fort Worth-Dallas area. After they pass the physical screening, all subjects must have an orientation visit in the lab to ensure the ability to tolerate wearing a face masker and breathing hypoxia air up to 5 minutes. In addition, they must undergo a series of cognitive assessments including clinical dementia rating to be determined to have MCI. Only the subjects who have been diagnosed with MCI are eligible to enroll to the study. Up to 66 MCI subjects will be recruited and assigned to two groups: intervention group to have intermittent hypoxia training (IHT) or control group with sham-IHT. The subjects in IHT group will breathe 10% O2 up to 5-min periods alternated with 5-min recovery on room air, repeated for 8 cycles per session, 3 sessions/week up to 12 weeks. The subjects in sham-IHT group will breathe 21% O2 and room air, each 5 min per cycle, for 8 cycles per session, 3 sessions/week for 12 weeks. Before and after 12-week interventions, the subjects' cognitive performances (including short-term memory, concentration ability, visuospatial orientation, and executive function), cardiovascular function during mental, physical and physiological challenges, blood plasma EPO, BDNF, and beta-amyloid proteins, carotid arterial morphology and function, brain MRI will be assessed and compared. In addition, the subjects' short-term memory, concentration ability, visuospatial orientation, and executive function in both groups will be assessed after 5-week and 8-week interventions to determine the IHT effect of a dose-response on the cognitive functions.
Eligibility Criteria
Age Range: 55 years to 79 years
Interventions
IHT Treatment
Sham-IHT Control
Conditions
Locations
University of North Texas Health Science Center
Fort Worth, Texas 76107
United States