An interventional study of IHT Treatment and Sham-IHT Control in Mild Cognitive Impairment and Memory Impairment, sponsored by University of North Texas Health Science Center. Recruiting at 1 site in United States. Open to participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of North Texas Health Science Center · Not applicable, Interventional, and Treatment
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).
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 66 is close to the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exposures to hypoxic air (10% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.
Device: IHT Treatment
Exposures to normoxic air (21% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.
Other: Sham-IHT Control
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.
Overall 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 after 12-week interventions
Attention and Short-term Memory
Change in scores or points in California-Verbal Learning Test - 2nd edition (CVLT-II), and Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate Free-Recall (FR) and delay FR for word-verbal memory and visuospatial memory.
Time frame: Change from baseline after 12-week interventions with IHT or sham-IHT
Cognitive Function in digit-verbal memory
Change in scores or points in Digit-Span test - Forward, backward and sequence. Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function in digit-verbal memory.
Time frame: Change from baseline after 12-week interventions
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 in executive function, attention and processing speed.
Time frame: Change from baseline after 12-week interventions
Brain Morphology
Cortical volume assessed by brain MRI scans. Increased cerebral cortical gray matter indicates a better outcome.
Time frame: before vs after up to 12-week intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Apr 2026, 38 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 38 months is above that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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University of North Texas Health Science Center