Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment
University of North Texas Health Science Center
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).
Description
Volunteer subjects 55-79 years age will sign an informed consent and complete a medical history form. The number of recruited minority subjects will be targeted to approximate the ethnic/racial demographics of the general population in Fort Worth-Dallas area. After they pass the physical screening, all subjects must have an orientation visit in the lab to ensure the ability to tolerate wearing a face masker and breathing hypoxia air up to 5 minutes. In addition, they must undergo a series of cognitive assessments including clinical dementia rating to be determined to have MCI. Only the subject…
Eligibility
- Age range
- 55–79 years
- Sex
- All
- Healthy volunteers
- No
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 con…
Interventions
- DeviceIHT 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.
- OtherSham-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.
Location
- University of North Texas Health Science CenterFort Worth, Texas