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NCT04280484 Clinical Trial

Acute Intermittent Hypoxia in Persons With Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04280484
Other study ID # STU00207024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2018
Est. completion date December 30, 2019

Study information
Verified date February 2020
Source Shirley Ryan AbilityLab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 30, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Shirley Ryan AbilityLab Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Shirley Ryan AbilityLab Edward Hines Jr. VA Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Voluntary Ankle Strength Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex 60 minutes post-intervention
Secondary Electromyogram activity Plantar-flexor and Dorsi-flexor electromyogram activity 60 minutes post-intervention
Secondary 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 60 minutes post-intervention
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