Back to results

IHT for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Memory Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IHT Treatment

Sham-IHT Control

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, and have no history of stroke or obstructive sleep apnea.
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), 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.

Sites / Locations

University of North Texas Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IHT Treatment

Sham-IHT control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Attention and Short-term Memory

Change in scores or points in California-Verbal Learning Test - 2nd edition. Immediate Free-Recall (FR), short-delay FR and long-delay FR for words. More FR words indicate better testing performance and function.

Cognitive Function

Change in scores or points in Digit-Span test. Two different sets of Forward (from 3 to 9 digits) and Backward (from 2 to 8 digits) Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function.

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.

Secondary Outcome Measures

Neurotoxic Protein

Blood beta-amyloid assessed by enzyme-linked immunosorbent assay. Decreased concentrations indicate a better outcome.

Neuroprotective Protein

Blood erythropoietin assessed by enzyme-linked immunosorbent assay. Increased concentrations indicate a better outcome.

Cerebral Vascular Function

Blood volume flow of carotid artery assessed by ultrasonography. Improved volume flow and vascular compliance in carotid arteries indicate a better outcome.

Brain Morphology

Thickness of cortical gray matter assessed by brain MRI. Increased cerebral cortical gray matter indicates a better outcome.

Full Information

NCT ID

NCT05495087

First Posted

July 13, 2022

Last Updated

April 3, 2023

Sponsor

University of North Texas Health Science Center

Collaborators

University of Texas Southwestern Medical Center, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05495087

Brief Title

IHT for Mild Cognitive Impairment

Official Title

Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2023 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Texas Health Science Center

Collaborators

University of Texas Southwestern Medical Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Memory Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

IHT vs Sham-IHT Control

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IHT Treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham-IHT control

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

IHT Treatment

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham-IHT Control

Intervention Description

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 Information:

Title

Overall Cognitive Function

Description

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

Time Frame

Change from baseline 5-week, 8-week, and up to 12-week intervention

Title

Attention and Short-term Memory

Description

Time Frame

Change from baseline 5-week, 8-week, and up to 12-week intervention

Title

Cognitive Function

Description

Time Frame

Change from baseline 5-week, 8-week, and up to 12-week intervention

Title

Visual Orientation and Executive Function

Description

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

Time Frame

Change from baseline 5-week, 8-week, and after up to 12-week intervention

Secondary Outcome Measure Information:

Title

Neurotoxic Protein

Description

Blood beta-amyloid assessed by enzyme-linked immunosorbent assay. Decreased concentrations indicate a better outcome.

Time Frame

before vs after up to 12-week intervention

Title

Neuroprotective Protein

Description

Blood erythropoietin assessed by enzyme-linked immunosorbent assay. Increased concentrations indicate a better outcome.

Time Frame

before vs after up to 12-week intervention

Title

Cerebral Vascular Function

Description

Blood volume flow of carotid artery assessed by ultrasonography. Improved volume flow and vascular compliance in carotid arteries indicate a better outcome.

Time Frame

before vs after up to 12-week intervention

Title

Brain Morphology

Description

Thickness of cortical gray matter assessed by brain MRI. Increased cerebral cortical gray matter indicates a better outcome.

Time Frame

before vs after up to 12-week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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), 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiangrong Shi, PhD

Phone

817-735-2073

xiangrong.shi@unthsc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Elaina Smith

Phone

817-735-2073

Elaina.Smith@unthsc.edu

Facility Information:

Facility Name

University of North Texas Health Science Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiangrong Shi, PhD

Phone

817-735-2689

xiangrong.shi@unthsc.edu

First Name & Middle Initial & Last Name & Degree

Elaina Smith

Phone

817-735-2073

Elaina.Smith@unthsc.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The summary results information of the trial will be shared, which will include participants' demographic and baseline characteristics, intermittent hypoxia training outcomes (including biosamples data) and statistical analyses, adverse events, and administrative information. All of the submitted results will be de-identified; no participant ID or identifiable information will be included in the shared results information.

IPD Sharing Time Frame

9 months after publication of major data for 3 years

IPD Sharing Access Criteria

Sharing the data by creating a record of the study in the Global Alzheimer's Association interactive Network (GAAIN.org).

Learn more about this trial

IHT for Mild Cognitive Impairment

We'll reach out to this number within 24 hrs