Improving Human Cerebrovascular Function Using Acute Intermittent Hypoxia

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    23
  • sponsor
    Northwestern University
Updated on 14 August 2023
Accepts healthy volunteers

Summary

This study uses magnetic resonance imaging to determine whether 3 weeks of repeated exposure to Acute Intermittent Hypoxia can improve brain blood flow or blood flow regulation in healthy adults.

Description

This study aims to identify an intervention to improve the function of blood vessels in the human brain, in order to mitigate damage to overall brain function and improve health outcomes across the lifespan. Hypoxia is a potent driver of angiogenesis and vascular plasticity, and acute intermittent hypoxia (AIH) protocols, in which an individual alternates between breathing mildly hypoxic air and normal air, are being rigorously examined for their potential in improving human physiology. This study tests whether AIH evokes beneficial vascular plasticity in the human brain, using a randomized crossover design to determine the impact of different daily AIH or sham interventions on MRI measures of cerebrovascular physiology.

Healthy, able-bodied participants between 21 and 50 years old will be invited to participate in this study. The daily AIH intervention consists of repeated visits to the PI laboratory over a three-week period to have an AIH or sham protocol administered via a hypoxia generator and face mask (Hyp-123, Hypoxico). Blood pressure readings will be taken before and after all intervention visits, and SpO2 levels continuously recorded for safety monitoring.

The effectiveness of the different interventions at improving cerebrovascular function will be assessed using MRI. In the week prior to each intervention period the participant will undergo MRI scanning. In addition to structural and diffusion weighted scans, multiple perfusion metrics will be extracted. Whole-brain cerebral blood flow will be measured using phase-contrast MRI, and quantitative CBF maps of regional perfusion will be measured using arterial spin labeling MRI. These perfusion metrics will be acquired three times: during normoxic (baseline), hypoxic, and hypercapnic conditions. Changes in perfusion values during gas challenges will measure whole-brain and regional cerebrovascular reactivity. The MRI protocol will be repeated one day after the last intervention visit.

Details
Condition Healthy Brain Perfusion
Treatment Sham Acute intermittent hypoxia, acute intermittent hypoxia
Clinical Study IdentifierNCT05164705
SponsorNorthwestern University
Last Modified on14 August 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy volunteers between ages of 21 and 50 years
No known neurological, respiratory or vascular conditions
Safe to be scanned using MRI
Able to communicate in English

Exclusion Criteria

MRI contraindications as indicated on MRI safety screening form
Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
Pregnant women
Individuals with known neurological or vascular conditions
Individuals with sleep apnea, emphysema, or other respiratory conditions
Individuals with severe claustrophobia
Subjects unwilling or unable to give written informed consent in English
Prisoners
Frequent smoker
Allergy to Tegaderm
Blood pressure greater than 160/110 or less than 85/55
Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study
Note, mild (well-controlled) asthma is not immediate grounds for exclusion
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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