IHT for Mild Cognitive Impairment

Last updated: April 3, 2023
Sponsor: University of North Texas Health Science Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mental Disability

Memory Loss

Dementia

Treatment

N/A

Clinical Study ID

NCT05495087
R01AG076675
R01AG076675
  • Ages 55-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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, suchas hypertension, coronary artery disease, diabetes or metabolic disease, chronicbronchitis, degenerative osteoporosis or arthritis and/or other aging-related chronicconditions.
  • Must be depression-free at the time of enrollment.
  • Must have arterial oxygen saturation at or above 95% and cerebral tissue oxygenationat or above 50% at rest.
  • Woman subject must be post-menopausal.

Exclusion

Exclusion Criteria:

  • Unwilling to sign a written consent to participate in this double-blindedplacebo-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 medicalhistory questionnaire), obstructive sleep apnea (based on the medical history),recurrent chest pain, seizures or epilepsies, moderate to severe carotid stenosis orcalcification, brain aneurysm, uncontrolled allergic rhinitis, pulmonary fibrosis,emphysema, cancer, infectious disease, atrial fibrillation, regular pre-matureventricular contractions, myocardial ischemia or infarct, 2nd or 3rd degreeatrio-ventricular blockade.
  • Have severe head injury or traumatic brain injury, stroke (hemorrhagic and/orischemic).
  • 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 previouslyexposed 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.

Study Design

Total Participants: 66
Study Start date:
February 27, 2023
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • University of North Texas Health Science Center

    Fort Worth, Texas 76107
    United States

    Active - Recruiting

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