Menu
Not yet recruiting NCT07631143

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

Phase I / Phase II Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute Intermittent Hypoxia.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

AIH is a treatment where people breathe reduced amounts of oxygen (10% oxygen) for a short period of time alternating with normal oxygen levels (21%) through a facemask that is attached to an oxygen tank with 10% 02. Participants will undergo 6 AIH treatment sessions over 3-4 weeks.

AIH will be administered to 3 unique groups of people: 1) People with advanced MS disability who are no longer ambulatory, 2) People who experienced a disabling relapse within the past 4 weeks and 3) People with non-active, progressive MS who retain some ambulatory ability.

There will be one baseline and two post-treatment assessments (1 and 5 weeks following the last AIH session).

Interventions

  • Other Acute Intermittent Hypoxia
    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

Primary outcome measures

  • SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm [Time frame: During the six AIH treatment session in weeks 1-4]
Secondary outcome measures (7)
  • Worsening on a verbal response 9-Item subjective symptom checklist [Time frame: During the six AIH treatment sessions in weeks 1-4]
  • Functional testing 1: Nine-Hole Peg test [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]
  • Functional testing 2: Symbol Digit Modalities Test [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]
  • Functional testing 3: Timed 25-Foot walk test [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]
  • Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]
  • Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]
  • Transcranial Magnetic Stimulation (TMS) [Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session]

Eligibility criteria

Inclusion criteria

\-

Group 1:

  • 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

Group 2:

  • People with a confirmed diagnosis of relapsing remitting MS
  • Acute disabling relapse onset within the past 4 weeks. A disabling relapse will be defined as at least 1.0-point increase on the EDSS.
  • Older than age 18

Group 3:

  • People with a confirmed diagnosis of MS that is non-active and progressive (Primary or Secondary Progressive MS). Non-active will be defined as without MS relapse, new/enlarging or enhancing MRI lesions within the past 1 year.
  • EDSS <=6.5
  • Older than age 18

Exclusion criteria

  • 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
  • Severe hypertension (>160/100)
  • Seizure disorders
  • Medically unstable in another capacity
  • Unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07631143 · Bio 4476 · LOxyMS USASK -0924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗