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OpenTrials
Completed

NCT Number: NCT04280484

Acute Intermittent Hypoxia 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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intermittent Hypoxia

Other

1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.

Sham Hypoxia

Other

1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.

Primary outcomes

  1. Voluntary Ankle Strength

    Time frame: 60 minutes post-intervention

    Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex

Secondary outcomes

  1. Electromyogram activity

    Time frame: 60 minutes post-intervention

    Plantar-flexor and Dorsi-flexor electromyogram activity

  2. 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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Edward Hines Jr. VA Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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