RecruitingNot ApplicableNCT05495087

IHT for Mild Cognitive Impairment

Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment

Sponsor

University of North Texas Health Science Center

Enrollment

66 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment Memory Impairment

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

Min Age: 55 YearsMax Age: 79 Years

Inclusion Criteria8

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 Criteria11

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.

Interested in this trial?

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Interventions

DEVICEIHT Treatment

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.

OTHERSham-IHT Control

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.