Enhancing Cognition in Older Adults With Intermittent Hypoxia and Cognitive Training

NCT03957213 | Completed

• 1 other identifier: IRB201802556
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will investigate methods for enhancing cognitive training (CT) effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with an intermittent hypoxia (IH) intervention. The investigators will compare changes in cognitive and brain function resulting from CT combined with active IH versus CT combined with sham IH using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during speed of processing; the active cognitive abilities trained by CT. Magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including ATP and GABA concentrations sensitive to neural plasticity.

Conditions

Aging

Keywords

Intermittent Hypoxia; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• Change in Posit Science Double Decision Performance

  Determine whether training performance improves when cognitive training (CT) is coupled with intermittent hypoxia (IH). Posit Science Double Decision is designed to improve the speed and accuracy with which the brain can process visual information, both at the center of gaze and on the periphery, known as "useful field of view" (UFOV). Scored in milliseconds, where lower scores indicate better processing speeds. CT will involve up to 10 hours of training over 2-weeks (10 days) and employs a PositScience BrainHQ suite via its researcher portal

  Baseline; Week 2

Study Arms (2)

Active IH + CT

EXPERIMENTAL

Acute intermittent hypoxia will be provided to the subject by delivering 15 brief exposures (\~60 seconds) of hypoxic air alternated with 15 brief exposures (\~60 seconds) of room air. The amount of oxygen delivered during hypoxic exposures may range from 15%-9% fraction of inspired oxygen, compared to 21% oxygen in normal atmospheric air. This is followed by a 30 minute rest period and then 60 minutes of computerized cognitive training.

Device: Acute Intermittent Hypoxia; Behavioral: Computerized Cognitive Training

Sham IH + CT

SHAM COMPARATOR

A sham protocol will be administered in which 21% fraction of inspired oxygen will be delivered by the hypoxicator during hypoxic intervals, and room air will be delivered through the four-way valve during room air intervals. This is followed by a 30 minute rest period and then 60 minutes of computerized cognitive training (Posit; Brain HQ).

Behavioral: Computerized Cognitive Training

Interventions

Acute Intermittent Hypoxia DEVICE

Acute intermittent hypoxia is a safe, non-invasive technique. All sessions will be monitored by research study staff trained in delivering acute intermittent hypoxia. Hypoxic intervals will be delivered with a commercially available sports performance hypoxicator. A unit capable of delivering a fraction of inspired oxygen ranging from 21%-9% will be used. Air will be delivered into a mask that will be secured comfortably over the subject's nose and mouth. Intervention sessions will occur for 10 days over a 2 week period.

Active IH + CT

Computerized Cognitive Training BEHAVIORAL

60 minutes of Double Decision cognitive training for 10 days over a 2 week period.

Active IH + CT; Sham IH + CT

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• English speaking
• Physically mobile
• Cognitive function between 0-79th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.

You may not qualify if:

• Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
• Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
• Past opportunistic brain infection
• Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
• Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
• MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
• Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
• Certain prescription CNS acting medications that alter the neuroplastic response of brain tissue (gabaergic and glutamatergic drugs).
• Hearing or vision deficits that will not allow for standardized cognitive training; ie colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
• Left handedness, as those with left-handedness have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data.
• Cancer (other than skin) within the last 3 years.
• Sleep apnea diagnosis or suspected sleep apnea.
• Heart failure or heart disease.
• Pulmonary disease.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Adam J Woods, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: June 1, 2019
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)