Acute Intermittent Hypoxia in Persons With Multiple Sclerosis

February 20, 2020 updated by: Milap Sandhu, Shirley Ryan AbilityLab

Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis

The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have relapsing-remitting MS
  • Volitional ankle plantar flexion strength in at least one leg
  • Are relapse free for 30 days
  • Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)

Exclusion Criteria:

  • Currently taking antispasticity medications,
  • Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
  • Pregnant or nursing women (safety for developing fetus or infant is unknown)
  • Cognitive concerns (must be able to consent to study, follow steps)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Intermittent Hypoxia
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts
Other: Intermittent Hypoxia
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Sham Comparator: Sham Acute Intermittent Hypoxia
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.
Other: Sham Hypoxia
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voluntary Ankle Strength
Time Frame: 60 minutes post-intervention
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
60 minutes post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyogram activity
Time Frame: 60 minutes post-intervention
Plantar-flexor and Dorsi-flexor electromyogram activity
60 minutes post-intervention
Symbol Digit Modalities Test
Time Frame: 60 minutes post-intervention
The symbol-digit modalities test (SDMT) is a symbol substitution neuropsychological test that examines a person's attention and speed of processing
60 minutes post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

Edward Hines Jr. VA Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00207024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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