Intermittent hypoxia training for mild cognitive impairment

Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment

This trial will test whether intermittent hypoxia training can improve thinking and memory in people aged 55–79 with mild cognitive impairment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 55 Years to 79 Years
• Sex: All
• Sponsor: University of North Texas Health Science Center (other)
• Locations: 1 site (Fort Worth, Texas)
• Trial ID: NCT05495087 on ClinicalTrials.gov

What this trial studies

This phase I, double-blinded, randomized trial will test safety and preliminary benefit of intermittent hypoxia training (IHT) versus a sham control in up to 66 adults aged 55–79 with mild cognitive impairment. Participants will be screened for tolerance to a facemask and brief hypoxia and then randomized to breathe 10% oxygen for up to 5-minute periods alternating with 5-minute room-air recovery (8 cycles per session, three sessions per week) for up to 12 weeks or to a sham protocol breathing 21% oxygen. Cognitive performance, cardiovascular responses to challenges, blood biomarkers including EPO, BDNF and beta-amyloid, and carotid artery structure will be measured before and after the intervention. The trial targets local recruitment in the Fort Worth–Dallas area and is conducted at the University of North Texas Health Science Center with collaborators including UT Southwestern and support from the National Institute on Aging.

Who should consider this trial

Good fit: Ideal candidates are adults 55–79 with a clinical diagnosis of mild cognitive impairment who are depression-free, post‑menopausal if female, can tolerate a facemask and brief hypoxia, and can travel to the Fort Worth lab for repeated sessions.

Not a fit: People with established Alzheimer’s dementia, significant respiratory or cardiovascular instability, low resting oxygen saturation, inability to tolerate the mask or hypoxia, or unwillingness to attend frequent in-person visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, IHT could provide a non-drug way to improve or slow decline in cognitive function for people with MCI.

How similar studies have performed: Preclinical studies and small human studies suggest intermittent hypoxia can increase neurotrophic factors and may aid cognition, but robust clinical evidence in MCI is currently limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 ≥1.
* 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), 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-19.
* 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.

Where this trial is running

Fort Worth, Texas

• University of North Texas Health Science Center — Fort Worth, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Xiangrong Shi, PhD

Conditions: Mild Cognitive Impairment, Memory Impairment, intermittent hypoxia training or preconditioning