Effect of Intermittent Hypoxia in Healthy Individuals

Effect of Acute 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy
• Intervention / Treatment: Other: Acute Intermittent Hypoxia; Other: Sham Acute Intermittent Hypoxia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acute Intermittent Hypoxia (AIH); Undergoing Acute Intermittent Hypoxia sessions	Other: Acute Intermittent Hypoxia; 30 minute session of Acute Intermittent Hypoxia
Placebo Comparator: Sham AIH; Undergoing Sham AIH sessions	Other: Sham Acute Intermittent Hypoxia; 30 minute session of Sham Acute Intermittent Hypoxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Grip Strength	Change in strength from before acute Intermittent hypoxia to after administration	Immediately after acute intermittent hypoxia administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fMRI	fMRI evaluating changes in blood flow before and after acute intermittent hypoxia administration	Immediately after acute intermittent hypoxia administration

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: William Rymer, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): March 1, 2022
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Acute Intermittent Hypoxia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: STU00202448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No