Actively Recruiting
IHT for Mild Cognitive Impairment
Led by University of North Texas Health Science Center · Updated on 2026-04-29
66
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
University of North Texas Health Science Center
Lead Sponsor
U
University of Texas Southwestern Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
IHT for Mild Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women ages 55 to 79 years old who have been diagnosed with MCI.
- Willing to be assigned to either treatment or sham-treatment control group.
- Able to attend multiple lab visits for assessments.
- Able to breathe moderately low-oxygen air via an air-cushioned disposable facemask.
- Have controlled and stable chronic conditions for at least 6 months, such as hypertension, coronary artery disease, diabetes, metabolic disease, chronic bronchitis, degenerative osteoporosis or arthritis, or other aging-related chronic conditions.
- Must be free of depression at enrollment.
- Have arterial oxygen saturation of 95% or higher and cerebral tissue oxygenation of 50% or higher at rest.
- Women must be post-menopausal.
You will not qualify if you...
- Unwilling to sign written consent for this double-blinded placebo-controlled phase I trial.
- Diagnosed with Alzheimer's disease dementia or have impaired independent daily functioning; MMSE less than 20 and/or Clinical Dementia Rating of 1 or higher.
- Unable to visit the lab independently.
- Claustrophobic to facemask or hyper-reactive to hypoxia exposure.
- Expecting major surgery or transplant.
- Have uncontrolled chronic conditions including blood pressure over 150/90 mmHg despite medications, diabetes, chronic renal failure, recurrent chest pain, seizures or epilepsy, moderate to severe carotid artery stenosis or calcification, brain aneurysm, uncontrolled allergic rhinitis, pulmonary fibrosis, emphysema, cancer, infectious disease, atrial fibrillation, regular premature ventricular contractions, myocardial ischemia or infarction, or certain heart blockades.
- Have severe head injury, traumatic brain injury, or stroke.
- Currently diagnosed with depression.
- Currently have COVID-19.
- Have metallic implants or are claustrophobic.
- Currently participating in any interventional study or previously exposed to hypoxia (living above 5000 ft for more than two months in past 3 years or prior hypoxia training study).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Actively Recruiting
Research Team
X
Xiangrong Shi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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