Improving Human Cerebrovascular Function Using Acute Intermittent Hypoxia

NCT05164705 | Completed DMC

• 1 other identifier: STU00215559
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Brain Perfusion

Keywords

Acute Intermittent Hypoxia; MRI; Perfusion; Cerebral Blood Flow; Cerebrovascular Reactivity

Outcome Measures

Primary Outcomes (1)

• Resting cerebral blood flow

  Phase-contrast MRI and Arterial Spin Labeling MRI will be used to quantify whole-brain and cortical gray matter perfusion (ml/100g/min) before and after the 3-week intervention.

  4 weeks

Secondary Outcomes (1)

• Cerebrovascular reactivity

  4 weeks

Study Arms (2)

Intermittent Hypoxia

ACTIVE COMPARATOR

Participant will visit our center 2-4 times per week for three weeks to receive Acute Intermittent Hypoxia.

Other: Acute Intermittent Hypoxia

Sham Intermittent Hypoxia

SHAM COMPARATOR

Participants will visit our center 2-4 times per week for three weeks to receive Sham Intermittent Hypoxia.

Other: Sham Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia OTHER

Participants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol.

Intermittent Hypoxia

Sham Acute Intermittent Hypoxia OTHER

Participants will wear a non-rebreathing face mask and breathe normal air (21 percent O2) for 30-minutes.

Sham Intermittent Hypoxia

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 140/90 or less than 90/55.
• Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study.
• Individuals prescribed Aripiprazole and/or Lamotrigine\*

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Johnson HR, Wang MC, Stickland RC, Chen Y, Parrish TB, Sorond FA, Bright MG. Variable cerebral blood flow responsiveness to acute hypoxic hypoxia. Front Physiol. 2025 Mar 12;16:1562582. doi: 10.3389/fphys.2025.1562582. eCollection 2025.

  PMID: 40144550 DERIVED

Study Officials

• Molly G Bright, DPhil

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know whether they are receiving active or sham hypoxia during individual AIH sessions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized sham-controlled crossover trial

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: May 3, 2022
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At time of publication (or within one year of project completion, whichever occurs first).
• Access Criteria: Data will be anonymized and made publicly available, and at that time no approval is needed and therefore there are no access criteria.

Locations

US (1)