Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2023-02-27
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
80 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
National Institute on Aging (NIA)
NIH
University of North Texas Health Science Center
OTHER
Responsible Party
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Xiangrong Shi
Associate Professor
Locations
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University of North Texas Health Science Center
Fort Worth, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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