RECRUITING

IHT for Mild Cognitive Impairment

Conditions

Mild Cognitive Impairment Memory Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment

Quick Facts

Study Start:2023-02-27

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05495087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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), obstructive sleep apnea (based on the medical history), 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.

Inclusion Criteria

Exclusion 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.

* 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), obstructive sleep apnea (based on the medical history), 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.

Contacts and Locations

Study Contact

Xiangrong Shi, PhD

CONTACT

817-735-2073

xiangrong.shi@unthsc.edu

Elaina Smith

CONTACT

817-735-2073

Elaina.Smith@unthsc.edu

Study Locations (Sites)

University of North Texas Health Science Center

Fort Worth, Texas, 76107

United States

Collaborators and Investigators

Sponsor: University of North Texas Health Science Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-02-27

Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

Mild Cognitive Impairment
Memory Impairment