NCT05513911

Brief Summary

In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record bicep muscle activations before and after bouts of AIH

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 22, 2022

Last Update Submit

August 22, 2022

Conditions

Keywords

Acute Intermittent HypoxiaMotor UnitUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Maximal Elbow Strength [Newtons]

    Recordings of the elbow joint torque are taken while the participant is asked to flex and extend the elbow voluntarily at a maximum level of intensity

    30 minutes Post intervention

Secondary Outcomes (1)

  • Biceps Brachii Muscle activation [μv]

    30 minutes post intervention

Study Arms (1)

Acute intermittent Hypoxia Therapy

EXPERIMENTAL

This group will receive the acute intermittent hypoxia therapy (9% O2) for 30 minutes. Before and after the intervention the participant will perform flexion of the elbow at various levels of intensity

Other: Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session

Also known as: AIH
Acute intermittent Hypoxia Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of Spinal Cord Injury from C3-T4
  • Non-progressive spinal cord injury
  • More than 6 months since initial Spinal Cord injury
  • Ability to understand and willingness to sign written informed consent

You may not qualify if:

  • Presence of any of the following medical conditions: Congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma
  • Persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis
  • Medical clearance will be required if participant is taking any other investigational agents
  • Women who are pregnant or nursing
  • Individuals with tracheostomy
  • Cannot pursue other research studies which may interfere
  • Unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Insemination, Artificial, Homologous

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • William Z Rymer, MD, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR
  • Milap Sandhu, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Every participant in this study will receive the intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

February 3, 2016

Primary Completion

November 8, 2016

Study Completion

March 25, 2019

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Overall participant Data will be reported in publications

Locations