Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
1 active site
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
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedFebruary 24, 2020
February 1, 2020
1.3 years
February 19, 2020
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Voluntary Ankle Strength
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
60 minutes post-intervention
Secondary Outcomes (2)
Electromyogram activity
60 minutes post-intervention
Symbol Digit Modalities Test
60 minutes post-intervention
Study Arms (2)
Acute Intermittent Hypoxia
EXPERIMENTAL1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts
Sham Acute Intermittent Hypoxia
SHAM COMPARATOR1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.
Interventions
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirley Ryan AbilityLablead
- Edward Hines Jr. VA Hospitalcollaborator
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 21, 2020
Study Start
June 18, 2018
Primary Completion
October 10, 2019
Study Completion
December 30, 2019
Last Updated
February 24, 2020
Record last verified: 2020-02