Acute Intermittent Hypoxia in Persons With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Other: Intermittent Hypoxia; Other: Sham Hypoxia

• Registration Number: NCT04280484
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Primary Completion: 2019-10-10
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-20
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acute Intermittent Hypoxia	Intermittent Hypoxia	1 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 Hypoxia	1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.

Primary Outcome Measures

Name	Time	Method
Voluntary Ankle Strength	60 minutes post-intervention	Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex

Secondary Outcome Measures

Name	Time	Method
Symbol Digit Modalities Test	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
Electromyogram activity	60 minutes post-intervention	Plantar-flexor and Dorsi-flexor electromyogram activity

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States