Back to resultsEffect of Intermittent Hypoxia in Healthy Individuals
Primary Purpose
Healthy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Intermittent Hypoxia
Sham Acute Intermittent Hypoxia
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Acute Intermittent Hypoxia
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
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acute Intermittent Hypoxia (AIH)
Sham AIH
Arm Description
Undergoing Acute Intermittent Hypoxia sessions
Undergoing Sham AIH sessions
Outcomes
Primary Outcome Measures
Change in Grip Strength
Change in strength from before acute Intermittent hypoxia to after administration
Secondary Outcome Measures
Full Information
NCT ID
NCT04691518
First Posted
December 22, 2020
Last Updated
July 25, 2022
Sponsor
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT04691518
Brief Title
Effect of Intermittent Hypoxia in Healthy Individuals
Official Title
Effect of Acute Intermittent Hypoxia in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Acute Intermittent Hypoxia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will participate in any of the interventions
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded to Treatment or Placebo treatment when applicable
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute Intermittent Hypoxia (AIH)
Arm Type
Active Comparator
Arm Description
Undergoing Acute Intermittent Hypoxia sessions
Arm Title
Sham AIH
Arm Type
Placebo Comparator
Arm Description
Undergoing Sham AIH sessions
Intervention Type
Other
Intervention Name(s)
Acute Intermittent Hypoxia
Intervention Description
30 minute session of Acute Intermittent Hypoxia
Intervention Type
Other
Intervention Name(s)
Sham Acute Intermittent Hypoxia
Intervention Description
30 minute session of Sham Acute Intermittent Hypoxia
Primary Outcome Measure Information:
Title
Change in Grip Strength
Description
Change in strength from before acute Intermittent hypoxia to after administration
Time Frame
Immediately after acute intermittent hypoxia administration
Other Pre-specified Outcome Measures:
Title
Change in fMRI
Description
fMRI evaluating changes in blood flow before and after acute intermittent hypoxia administration
Time Frame
Immediately after acute intermittent hypoxia administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Rymer, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intermittent Hypoxia in Healthy Individuals
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