Recruiting

IHT

Sponsor:

University of North Texas Health Science Center

Code:

NCT05495087

Conditions

Mild Cognitive Impairment

Memory Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

IHT Treatment

Sham-IHT Control

Study Details

Brief 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).

Conditions

Mild Cognitive Impairment

Memory Impairment

Study ID

NCT05495087

Start date

Feb 27, 2023

Status verified date

Apr, 2026

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IHT Treatment

Exposures to hypoxic air (10% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.

placebo comparator: Sham-IHT control

Exposures to normoxic air (21% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.

Interventions

IHT 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.

Sham-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.

Primary outcome measure

  • Overall Cognitive Function [ Time Frame: Change from baseline after 12-week interventions ]
  • Attention and Short-term Memory [ Time Frame: Change from baseline after 12-week interventions with IHT or sham-IHT ]
  • Cognitive Function in digit-verbal memory [ Time Frame: Change from baseline after 12-week interventions ]
  • Visual Orientation and Executive Function [ Time Frame: Change from baseline after 12-week interventions ]

Central Contacts and Locations

Central contacts

Xiangrong Shi, PhD

817-735-2073xiangrong.shi@unthsc.edu

Locations

University of North Texas Health Science Center

Recruiting

Fort Worth, Texas, United States, 76107

Contacts

Xiangrong Shi, PhD

8177352689xiangrong.shi@unthsc.edu

More Information

Sponsor

University of North Texas Health Science Center

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • intermittent hypoxia training or preconditioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Texas Health Science Center on 2026-04-29.