IHT for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Texas Health Science Center
Disqualifiers: AD-dementia, Uncontrolled conditions, Depression, others
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it requires that any chronic conditions you have are controlled and stabilized for at least 6 months.
What data supports the effectiveness of the treatment IHT for Mild Cognitive Impairment?
Research shows that intermittent hypoxia training (IHT) can improve short-term memory and attention in elderly patients with mild cognitive impairment by enhancing brain oxygenation and blood flow. Another study found that a similar approach, intermittent hypoxia-hyperoxia training, improved cognitive function and reduced inflammation in patients with mild cognitive impairment.12345
How is IHT Treatment different from other treatments for mild cognitive impairment?
IHT Treatment (Intermittent Hypoxia Training) is unique because it involves exposing patients to short periods of low oxygen levels, which is different from other treatments like cognitive training or cholinesterase inhibitors that focus on enhancing brain function through exercises or chemicals. This approach is novel as it uses a physiological method to potentially improve cognitive function.678910
Eligibility Criteria
This trial is for adults aged 55-79 with mild cognitive impairment (MCI). Participants must be depression-free, post-menopausal if female, have certain stable chronic conditions, and able to visit the lab. Exclusions include major upcoming surgery, current severe illnesses like uncontrolled hypertension or diabetes, recent high-altitude living, metal implants, or claustrophobia to facemasks.Inclusion Criteria
I can breathe through a special mask with less oxygen.
You should not have depression when you join the study.
My chronic conditions like high blood pressure or diabetes have been stable for at least 6 months.
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Exclusion Criteria
You are currently in another research study or have been in a study that involved low oxygen levels, like living at high altitudes or being in a hypoxia training program.
I have had a severe head or brain injury, or a stroke.
I currently have COVID-19.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo intermittent hypoxia training (IHT) or sham-IHT control for up to 12 weeks, with 3 sessions per week
12 weeks
3 sessions per week
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- IHT Treatment (Other)
- Sham-IHT Control (Other)
Trial OverviewThe study tests intermittent hypoxia training (IHT) versus a sham control over 12 weeks to see if it's safe and effective for improving memory in people with MCI. Participants will breathe moderately hypoxic air through a mask and are randomly assigned to either the treatment or placebo group.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IHT TreatmentExperimental Treatment1 Intervention
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.
Group II: Sham-IHT controlPlacebo Group1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Texas Health Science CenterFort Worth, TX
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Who Is Running the Clinical Trial?
University of North Texas Health Science CenterLead Sponsor
University of Texas Southwestern Medical CenterCollaborator
National Institute on Aging (NIA)Collaborator
References
Intermittent Hypoxia Training for Treating Mild Cognitive Impairment: A Pilot Study. [2020]Although intermittent hypoxia training (IHT) has proven effective against various clinical disorders, its impact on mild cognitive impairment (MCI) is unknown. This pilot study examined IHT's safety and therapeutic efficacy in elderly patients with amnestic MCI (aMCI). Seven patients with aMCI (age 69 ± 3 years) alternately breathed 10% O2 and room-air, each 5 minutes, for 8 cycles/session, 3 sessions/wk for 8 weeks. The patients' resting arterial pressures fell by 5 to 7 mm Hg (P < .05) and cerebral tissue oxygenation increased (P < .05) following IHT. Intermittent hypoxia training enhanced hypoxemia-induced cerebral vasodilation (P < .05) and improved mini-mental state examination and digit span scores from 25.7 ± 0.4 to 27.7 ± 0.6 (P = .038) and from 24.7 ± 1.2 to 26.1 ± 1.3 (P = .047), respectively. California verbal learning test score tended to increase (P = .102), but trail making test-B and controlled oral word association test scores were unchanged. Adaptation to moderate IHT may enhance cerebral oxygenation and hypoxia-induced cerebrovasodilation while improving short-term memory and attention in elderly patients with aMCI.
Response of Circulating Inflammatory Markers to Intermittent Hypoxia-Hyperoxia Training in Healthy Elderly People and Patients with Mild Cognitive Impairment. [2023]Intermittent hypoxia-hyperoxia training (IHHT) is a non-pharmacological therapeutic modality for management of some chronic- and age-related pathologies, such as Alzheimer’s disease (AD). Our previous studies demonstrated significant improvement of cognitive function after IHHT in the patients with mild cognitive impairment (MCI). The present study further investigated the effects of IHHT on pro-inflammatory factors in healthy elderly individuals and patients with early signs of AD. Twenty-nine subjects (13 healthy subjects without signs of cognitive impairment syndrome and 16 patients diagnosed with MCI; age 52 to 76 years) were divided into four groups: Healthy+Sham (n = 7), Healthy+IHHT (n = 6), MCI+Sham (n = 6), and MCI+IHHT (n = 10). IHHT was carried out 5 days per week for 3 weeks (total 15 sessions), and each daily session included 4 cycles of 5-min hypoxia (12% FIO2) and 3-min hyperoxia (33% FIO2). Decline in cognitive function indices was observed initially in both MCI+Sham and MCI+IHHT groups. The sham training did not alter any of the parameters, whereas IHHT resulted in improvement in latency of cognitive evoked potentials, along with elevation in APP110, GDF15 expression, and MMP9 activity in both healthy subjects and those with MCI. Increased MMP2 activity, HMGB1, and P-selectin expression and decreased NETs formation and Aβ expression were also observed in the MCI+IHHT group. There was a negative correlation between MoCA score and the plasma GDF15 expression (R = −0.5799, p
Chronic intermittent hypoxia/reoxygenation facilitate amyloid-β generation in mice. [2022]Previous studies have shown a high prevalence of obstructive sleep apnea (OSA) among patients with Alzheimer's disease (AD). However, it is poorly assessed whether chronic intermittent hypoxia (CIH), which is a characteristic of OSA, affects the pathophysiology of AD. We aimed to investigate the direct effect of intermittent hypoxia (IH) in pathophysiology of AD in vivo and in vitro. In vivo, 15 male triple transgenic AD mice were exposed to either CIH or normoxia (5% O2 and 21% O2 every 10 min, 8 h/day for 4 weeks). Amyloid-β (Aβ) profile, cognitive brain function, and brain pathology were evaluated. In vitro, human neuroblastoma SH-SY5Y cells stably expressing wild-type amyloid-β protein precursor were exposed to either IH (8 cycles of 1% O2 for 10 min followed by 21% O2 for 20 min) or normoxia. The Aβ profile in the conditioned medium was analyzed. CIH significantly increased levels of Aβ42 but not Aβ40 in the brains of mice without the increase in hypoxia-inducible factor 1, alpha subunit (HIF-1α) expression. Furthermore, CIH significantly increased intracellular Aβ in the brain cortex. There were no significant changes in cognitive function. IH significantly increased levels of Aβ42 in the medium of SH-SY5Y cells without the increase in the HIF-1α expression. CIH directly and selectively increased levels of Aβ42 in the AD model. Our results suggest that OSA would aggravate AD. Early detection and intervention of OSA in AD may help to alleviate the progression of the disease.
[Prevention of the brain neurodegeneration in rats with experimental Alzheimer's disease by adaptation to hypoxia]. [2016]The study focused on a possibility of preventing brain neurodegeneration by adaptation to intermittent hypoxia (AH) in rats with experimental Alzheimer's disease (AD) modeled by injection of a neurotoxic bert-amyloid peptide fragment (Ab) into n. basalis magnocellularis. AH was produ- ced in an altitude chamber (4.000 m; 4 hours daily; 14 days). The following results were obtained after fifteen days of the Ab injection: (1) AH substantially prevented the memory impairment induced by Ab, which was determined using the conditioned avoidance reflex test; (2) the AH significantly restricted the enhanced oxidative stress, which was determined spectrophotometrically by thiobarbituric acid-reactive substance level in the hippocampus; (3) the AH completely prevented Ab-induced nitric oxide (NO) overproduction in brain, which was measured by tissue level of nitrite and nitrate; (4) pathologically changed and dead neurons (Niessle staining) were absent in the brain cortex of rats exposed to AH before the Ab injection. Therefore AH seems to effectively prevent oxidative and nitrosative stress thereby providing protection of brain against neurodegeneration and preservation of cognitive function in experimental AD.
A pilot study of sleep, cognition, and respiration under 4 weeks of intermittent nocturnal hypoxia in adult humans. [2021]A pilot study to examine the effects of intermittent nocturnal hypoxia on sleep, respiration and cognition in healthy adult humans.
Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed. [2021]Cognitive training (CT) may have benefits for both healthy older adults (HC) and those with early cognitive disorders [mild cognitive impairment (MCI) and dementia]. However, few studies have qualitatively evaluated home-based, computerized CT programs.
A randomized, double-blind, placebo-controlled, parallel-group 12-week pilot phase II trial of SaiLuoTong (SLT) for cognitive function in older adults with mild cognitive impairment. [2023]This study primarily aimed to evaluate the efficacy and safety of SaiLuoTong (SLT) on cognition in mild cognitive impairment (MCI).
Impact of cognitive intervention on cognitive symptoms and quality of life in idiopathic Parkinson's disease: a randomized and controlled study. [2022]Pharmacological treatments for mild cognitive impairment (MCI), are lacking, and alternative approaches have been implemented, including cognitive training (CT).
Key lessons learned from short-term treatment trials of cholinesterase inhibitors for amnestic MCI. [2022]This paper reviews the key lessons learned from the first published short-term, placebo-controlled trial of a cholinesterase inhibitor for treatment of mild cognitive impairment (MCI).
Neuroimaging Outcomes in Studies of Cognitive Training in Mild Cognitive Impairment and Early Alzheimer's Disease: A Systematic Review. [2021]Cognitive Training (CT) has demonstrated some benefits to cognitive and psychosocial function in Mild Cognitive Impairment (MCI) and early dementia, but the certainty related to those findings remains unclear. Therefore, understanding the mechanisms by which CT improves cognitive functioning may help to understand the relationships between CT and cognitive function. The purpose of this review was to identify the evidence for neuroimaging outcomes in studies of CT in MCI and early Alzheimer's Disease (AD).