IHT for Mild Cognitive Impairment

NCT05495087 | Recruiting DMC

• 1 other identifier: R01AG076675
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

intermittent hypoxia training or preconditioning

Outcome Measures

Primary Outcomes (4)

• Overall Cognitive Function

  Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function.

  Change from baseline after 12-week interventions

• Attention and Short-term Memory

  Change in scores or points in California-Verbal Learning Test - 2nd edition (CVLT-II), and Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate Free-Recall (FR) and delay FR for word-verbal memory and visuospatial memory.

  Change from baseline after 12-week interventions with IHT or sham-IHT

• Cognitive Function in digit-verbal memory

  Change in scores or points in Digit-Span test - Forward, backward and sequence. Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function in digit-verbal memory.

  Change from baseline after 12-week interventions

• Visual Orientation and Executive Function

  Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function in executive function, attention and processing speed.

  Change from baseline after 12-week interventions

Secondary Outcomes (1)

• Brain Morphology

  before vs after up to 12-week intervention

Study Arms (2)

IHT Treatment

EXPERIMENTAL

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.

Device: IHT Treatment

Sham-IHT control

PLACEBO COMPARATOR

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.

Other: Sham-IHT Control

Interventions

IHT Treatment DEVICE

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.

IHT Treatment

Sham-IHT Control OTHER

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.

Sham-IHT control

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• University of Texas Southwestern Medical Center: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiangrong Shi, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: IHT vs Sham-IHT Control

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: August 10, 2022
• Study Start: February 27, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)