Back to resultsAcute Intermittent Hypoxia in Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Hypoxia
Sham Hypoxia
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility Criteria
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)
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acute Intermittent Hypoxia
Sham Acute Intermittent Hypoxia
Arm Description
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.
Outcomes
Primary Outcome Measures
Voluntary Ankle Strength
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
Secondary Outcome Measures
Electromyogram activity
Plantar-flexor and Dorsi-flexor electromyogram activity
Symbol Digit Modalities Test
The symbol-digit modalities test (SDMT) is a symbol substitution neuropsychological test that examines a person's attention and speed of processing
Full Information
NCT ID
NCT04280484
First Posted
February 19, 2020
Last Updated
February 20, 2020
Sponsor
Shirley Ryan AbilityLab
Collaborators
Edward Hines Jr. VA Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04280484
Brief Title
Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
Official Title
Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Edward Hines Jr. VA Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute Intermittent Hypoxia
Arm Type
Experimental
Arm Description
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts
Arm Title
Sham Acute Intermittent Hypoxia
Arm Type
Sham Comparator
Arm Description
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.
Intervention Type
Other
Intervention Name(s)
Intermittent Hypoxia
Intervention Description
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Intervention Type
Other
Intervention Name(s)
Sham Hypoxia
Intervention Description
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Primary Outcome Measure Information:
Title
Voluntary Ankle Strength
Description
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
Time Frame
60 minutes post-intervention
Secondary Outcome Measure Information:
Title
Electromyogram activity
Description
Plantar-flexor and Dorsi-flexor electromyogram activity
Time Frame
60 minutes post-intervention
Title
Symbol Digit Modalities Test
Description
The symbol-digit modalities test (SDMT) is a symbol substitution neuropsychological test that examines a person's attention and speed of processing
Time Frame
60 minutes post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
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