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Enrolling by invitation NCT04691518

Effect of Intermittent Hypoxia in Healthy Individuals

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute Intermittent Hypoxia, Sham Acute Intermittent Hypoxia.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Acute Intermittent Hypoxia in Healthy Individuals

Overview

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.

Detailed description

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.

Interventions

  • Other Acute Intermittent Hypoxia
    30 minute session of Acute Intermittent Hypoxia
  • Other Sham Acute Intermittent Hypoxia
    30 minute session of Sham Acute Intermittent Hypoxia

Primary outcome measures

  • Change in Grip Strength [Time frame: Immediately after acute intermittent hypoxia administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT04691518 · STU00202448

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗