Viewing Study NCT04691518



Ignite Creation Date: 2024-05-06 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 1:53 PM
Study NCT ID: NCT04691518
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2023-11-24
First Post: 2020-12-22

Brief Title: Effect of Intermittent Hypoxia in Healthy Individuals
Sponsor: Shirley Ryan AbilityLab
Organization: Shirley Ryan AbilityLab

Study Overview

Official Title: Effect of Acute Intermittent Hypoxia in Healthy Individuals
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None