AgingEXCITENCT03957213
Enhancing Cognition in Older Adults With Intermittent Hypoxia and Cognitive Training
A study testing Acute Intermittent Hypoxia and Computerized Cognitive Training in people with Aging, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Acute Intermittent Hypoxia and Computerized Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- English speaking
- Physically mobile
- Cognitive function between 0-79th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Enhancing Cognition in Older Adults With Intermittent Hypoxia and Cognitive Training: The EXCITE Study
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.
Read the detailed description
Age-related cognitive decline has become a major public health concern. As the population ages, the number of older adults experiencing cognitive and functional disturbances has increased. There is currently a paucity of effective interventions to prevent or treat cognitive decline or to enhance brain function in the elderly. The proposed study will recruit a cohort from the state with the highest growth of older adults. The study team will employ a randomized controlled trial (RCT) to test whether the benefits of cognitive training (CT) can be enhanced by a combined adjunctive intervention aimed at increasing neural plasticity and optimizing readiness for learning: intermittent hypoxia (IH).
Current CT approaches have been shown to improve performance on trained tasks, with effects lasting up to ten years. However, generalization of effects to other cognitive domains and everyday functioning has been a problem in the past. There is now compelling evidence that the elderly do experience functional improvements that persist long after initial training, though peoples' ability to derive such benefits varies. Combined interventions have rarely been examined and methods aimed at increasing neural plasticity and optimizing readiness for learning are only now beginning to be explored. The proposed study will test one theoretical approach for facilitating and optimizing CT effects on functional outcome. The investigators will use an adjunctive physiological method to further stimulate task-related brain regions, directly enhancing neural responsivity/plasticity and ultimately learning. While theoretical rationales exist for each of these approaches, no studies to date have shown whether adjunctive administration can optimize learning and functional status in the elderly.
A pilot randomized clinical trial will enroll 55 participants, with a target of 20 participants completing the study, and as many as 30 participants consenting but failing to meet inclusion criteria at in person screening, and 5 participants withdrawing prior to completion. Cognitively healthy elderly adults, age 65-89 will undergo either a CT intervention in combination with IH or sham IH control. The CT intervention will employ the Double Decision task from the POSIT Science Brain HQ; a well validated CT method for enhancing cognitive functioning in the elderly. Participants will receive IH or sham/placebo IH administered during training.
Participants will be assessed at baseline and after CT (2 weeks). At each time point, a comprehensive neurocognitive, clinical and multimodal neuroimaging assessment of brain function, metabolic state, and brain structure will be conducted.
FMRI will be used to assess brain response during working memory, attention and memory encoding. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including gamma-aminobutyric acid (GABA) concentrations, sensitive to neural plasticity in task-associated brain regions.
- Conditions
- Aging
- Being tested
- Acute Intermittent Hypoxia, Computerized Cognitive Training
- Keywords
- Intermittent Hypoxia, Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent HypoxiaDevice
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.
Computerized Cognitive TrainingBehavioural
60 minutes of Double Decision cognitive training for 10 days over a 2 week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline; Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jun 2019
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam J Woods, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957213
- Sponsor's protocol ID
- IRB201802556
- Acronym
- EXCITE
- Status last verified
- Jan 2022
- First submitted
- 17 May 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognition in Older Adults With Intermittent Hypoxia and Cognitive Training: The EXCITE Study
- ClinicalTrials.gov ID
- NCT03957213
- Acronym / sponsor ID
- EXCITE / IRB201802556
- Conditions
- Aging
- Keywords
- Intermittent Hypoxia, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Age-related cognitive decline has become a major public health concern. As the population ages, the number of older adults experiencing cognitive and functional disturbances has increased. There is currently a paucity of effective interventions to prevent or treat cognitive decline or to enhance brain function in the elderly. The proposed study will recruit a cohort from the state with the highest growth of older adults. The study team will employ a randomized controlled trial (RCT) to test whether the benefits of cognitive training (CT) can be enhanced by a combined adjunctive intervention aimed at increasing neural plasticity and optimizing readiness for learning: intermittent hypoxia (IH).
Current CT approaches have been shown to improve performance on trained tasks, with effects lasting up to ten years. However, generalization of effects to other cognitive domains and everyday functioning has been a problem in the past. There is now compelling evidence that the elderly do experience functional improvements that persist long after initial training, though peoples' ability to derive such benefits varies. Combined interventions have rarely been examined and methods aimed at increasing neural plasticity and optimizing readiness for learning are only now beginning to be explored. The proposed study will test one theoretical approach for facilitating and optimizing CT effects on functional outcome. The investigators will use an adjunctive physiological method to further stimulate task-related brain regions, directly enhancing neural responsivity/plasticity and ultimately learning. While theoretical rationales exist for each of these approaches, no studies to date have shown whether adjunctive administration can optimize learning and functional status in the elderly.
A pilot randomized clinical trial will enroll 55 participants, with a target of 20 participants completing the study, and as many as 30 participants consenting but failing to meet inclusion criteria at in person screening, and 5 participants withdrawing prior to completion. Cognitively healthy elderly adults, age 65-89 will undergo either a CT intervention in combination with IH or sham IH control. The CT intervention will employ the Double Decision task from the POSIT Science Brain HQ; a well validated CT method for enhancing cognitive functioning in the elderly. Participants will receive IH or sham/placebo IH administered during training.
Participants will be assessed at baseline and after CT (2 weeks). At each time point, a comprehensive neurocognitive, clinical and multimodal neuroimaging assessment of brain function, metabolic state, and brain structure will be conducted.
FMRI will be used to assess brain response during working memory, attention and memory encoding. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including gamma-aminobutyric acid (GABA) concentrations, sensitive to neural plasticity in task-associated brain regions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IH + CT | Experimental | Device: Acute Intermittent Hypoxia, Behavioral: Computerized Cognitive TrainingAcute 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. |
| Sham IH + CT | Sham comparator | Behavioral: Computerized Cognitive TrainingA 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). |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- English speaking
- Physically mobile
- Cognitive function between 0-79th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent HypoxiaAcute 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. | Device | Active IH + CT |
| Computerized Cognitive Training60 minutes of Double Decision cognitive training for 10 days over a 2 week period. | Behavioural | Active IH + CT, Sham IH + CT |
Primary outcome
Change in Posit Science Double Decision Performance
Time frame: Baseline; Week 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam J Woods, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia and Computerized Cognitive Training in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posit Science Double Decision Performance (time frame: Baseline; Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.