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

NCT07631143 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: Bio 4476LOxyMS USASK -0924
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Acute Intermittent Hypoxia

Outcome Measures

Primary Outcomes (1)

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

  Number of episodes of each outcome

  During the six AIH treatment session in weeks 1-4

Secondary Outcomes (7)

• Worsening on a verbal response 9-Item subjective symptom checklist

  During the six AIH treatment sessions in weeks 1-4

• Functional testing 1: Nine-Hole Peg test

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

• Functional testing 2: Symbol Digit Modalities Test

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

• Functional testing 3: Timed 25-Foot walk test

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

• Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29)

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

Study Arms (1)

Treatment

EXPERIMENTAL

Acute Intermittent Hypoxia

Other: Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Katherine B Knox, MD, FRPC

CONTACT

306-655-7742; Katherine.knox@saskatoonhealthregion.ca

Sarah Donkers, PhD

CONTACT

306-966-3230; sarah.donkers@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot interventional study where the investigational drug product is 10% oxygen delivered intermittently. (No Objection Letter File # from Health Canada HC6-024-c292683)

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06