Effect of Intermittent Hypoxia in Healthy Individuals

NCT04691518 | Enrolling By Invitation

• 1 other identifier: STU00202448
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Acute Intermittent Hypoxia

Outcome Measures

Primary Outcomes (1)

• Change in Grip Strength

  Change in strength from before acute Intermittent hypoxia to after administration

  Immediately after acute intermittent hypoxia administration

Other Outcomes (1)

• Change in fMRI

  Immediately after acute intermittent hypoxia administration

Study Arms (2)

Acute Intermittent Hypoxia (AIH)

ACTIVE COMPARATOR

Undergoing Acute Intermittent Hypoxia sessions

Other: Acute Intermittent Hypoxia

Sham AIH

PLACEBO COMPARATOR

Undergoing Sham AIH sessions

Other: Sham Acute Intermittent Hypoxia

Interventions

Sham Acute Intermittent Hypoxia OTHER

30 minute session of Sham Acute Intermittent Hypoxia

Sham AIH

Acute Intermittent Hypoxia OTHER

30 minute session of Acute Intermittent Hypoxia

Acute Intermittent Hypoxia (AIH)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Study Officials

• William Rymer, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to Treatment or Placebo treatment when applicable
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Sensory Motor Performance Program

Model Details: Participants will participate in any of the interventions

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 31, 2020
• Study Start: November 16, 2016
• Primary Completion: March 1, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)