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Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With MS

ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Saskatchewan

About this trial

This study will look at the safety, tolerability and feasibility of a non-invasive treatment called Acute Intermittent Hypoxia (AIH) in people with Multiple Sclerosis (MS) at different stages of the disease course.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

People with a confirmed diagnosis of MS and advanced disability level (Expanded Disability Status Scale (EDSS) >6.5 and <9)

Without relapse for at least 90 days prior

Older than age 18

People with a confirmed diagnosis of relapsing remitting MS

Disqualifiers

Pregnancy

Any of the following documented respiratory disorders: obstructive sleep apnea, chronic obstructive pulmonary disease, uncontrolled asthma, hypoxic pulmonary disease, respiratory infection in the previous 3 months

Ischemic cardiac disease

Cardiac arrhythmia

Trial design

Design model

Single group

Treatments tested in this trial

  • Acute Intermittent Hypoxia

    Other intervention

    Hypoxia (10% O2) will be administered via a non-rebreather face mask connected to an oxygen tank supplying the 10% O2. Each session will involve 15 cycles of hypoxia, each lasting 90 seconds, interspersed with 60 second cycles of normoxia. The total duration of each session will be approximately 37 minutes. An inline oxygen analyzer will allow recording of the percentage of oxygen being delivered. A fingertip pulse-oximeter will be worn throughout to ensure that oxygen saturation (SpO2) falls to a nadir between 80 - 87% during hypoxic episodes and heart rate monitoring will be performed. Blood pressure will be checked prior to and following each session (within 5 minutes of treatment cessation).

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm

Number of episodes of each outcome

Time frame
During the six AIH treatment session in weeks 1-4

Secondary outcomes

1

Worsening on a verbal response 9-Item subjective symptom checklist

Symptom checklist to be administered during AIH treatments. Includes the following: Chest pain, shortness of breath, lightheadedness, neck pain, dizziness, arm pain (left side for cardiac symptoms), sweatiness/feeling warm, sensory changes and increased weakness.

Time frame
During the six AIH treatment sessions in weeks 1-4
2

Functional testing 1: Nine-Hole Peg test

A test of hand function and dexterity

Time frame
Baseline, 1- and 5- weeks after the final AIH treatment session
3

Functional testing 2: Symbol Digit Modalities Test

A cognitive test of processing speed

Time frame
Baseline, 1- and 5- weeks after the final AIH treatment session
4

Functional testing 3: Timed 25-Foot walk test

A test of gait

Time frame
Baseline, 1- and 5- weeks after the final AIH treatment session

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Saskatchewan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: