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Clinical trial Recruiting at 1 site Interventional Ages 55 to 79

Intermittent hypoxia training for mild cognitive impairment

Official title: Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment

Run by University of North Texas Health Science Center · NCT05495087 · Data updated 2026-11-12

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

Quick facts

Study typeInterventional
Ages55 Years to 79 Years
SexAll
Enrollment66 (estimated)
SponsorUniversity of North Texas Health Science Center
Academic / other
Locations1 site (Fort Worth, Texas)
StatusRecruiting
StartedFebruary 27, 2023
Main results expectedApril 30, 2026
Study endsApril 30, 2026
Registry record updatedApril 29, 2026
Trial IDNCT05495087 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • University of North Texas Health Science Center
    Fort Worth, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Mild Cognitive Impairment 267Memory Impairment 28University of North Texas Health Science Center 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.