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Enrolling by Invitation

NCT Number: NCT04691518

Effect of Intermittent Hypoxia in Healthy Individuals

The use of acute intermittent hypoxia (AIH) has been examined in animal and human studies to gain an understanding of its effect on spinal excitability and synaptic strength. Subsequently, the investigators have learned that the use of AIH results in new protein formation and spinal plasticity. The use of acute intermittent hypoxia demonstrates a potential for therapeutic utilization in individuals with neurologic injuries. However, little is known about the effect of AIH in healthy individuals. This work is necessary to understand the mechanisms of AIH-induced plasticity. As such, this research study seeks to evaluate the impact of a single session AIH on upper extremity motor function in healthy individuals.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

The use of acute intermittent hypoxia (AIH), has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Although AIH has proven to be a promising treatment in enhancing spinal excitability and strengthening existing synaptic connections within individuals with chronic spinal cord injuries, further examination also needs to be made on the impact of AIH on motor function in healthy individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No history of neurologic injury or progressive neuromuscular disorder
  • Individuals ages 18-70 years old
  • Must be medically stable with no history of cardiovascular instability, congestive heart failure or stroke
  • Not currently (>2 weeks) on any medications related to spasticity
  • No history of Sleep apnea
  • Not a current smoker
  • Able to comply with protocol/study requirements

Exclusion criteria

  • Recent change in the use of narcotic, anti-inflammatory or pain medication
  • unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study determined by the treating therapist or coordinating staff
  • Active participation in another movement research study or therapy program
  • Anti-spasticity drug injection less than 3 months prior to beginning treatment
  • Musculoskeletal pain that interferes with participation in study
  • Women who are currently, may be, or planning on becoming pregnant
  • for fMRI participation, participants will be excluded if they have:
  • Metal fragments in eyes or face
  • Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlea implants, or nerve stimulators
  • Vascular surgery
  • Claustrophobia
  • Body piercing or tattoos

Treatment and study plan

Acute Intermittent Hypoxia

Other

30 minute session of Acute Intermittent Hypoxia

Sham Acute Intermittent Hypoxia

Other

30 minute session of Sham Acute Intermittent Hypoxia

Primary outcomes

  1. Change in Grip Strength

    Time frame: Immediately after acute intermittent hypoxia administration

    Change in strength from before acute Intermittent hypoxia to after administration

Other outcomes

  1. Change in fMRI

    Time frame: Immediately after acute intermittent hypoxia administration

    fMRI evaluating changes in blood flow before and after acute intermittent hypoxia administration

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Effect of Acute Intermittent Hypoxia in Healthy Individuals

Important dates

Study start
2016
Primary completion
2022
Study completion
2026
First posted
Dec 31, 2020
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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