Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With MS (LOxyMS)
2 juni 2026 uppdaterad av: Katherine Knox, University of Saskatchewan
Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With Multiple Sclerosis
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Beräknad)
9
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Katherine B Knox, MD, FRPC
- Telefonnummer: 306-655-7742
- E-post: Katherine.knox@saskatoonhealthregion.ca
Studera Kontakt Backup
- Namn: Sarah Donkers, PhD
- Telefonnummer: 306-966-3230
- E-post: sarah.donkers@usask.ca
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment
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 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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm
Tidsram: During the six AIH treatment session in weeks 1-4
|
Number of episodes of each outcome
|
During the six AIH treatment session in weeks 1-4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Worsening on a verbal response 9-Item subjective symptom checklist
Tidsram: During the six AIH treatment sessions in weeks 1-4
|
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.
|
During the six AIH treatment sessions in weeks 1-4
|
|
Functional testing 1: Nine-Hole Peg test
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
A test of hand function and dexterity
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
|
Functional testing 2: Symbol Digit Modalities Test
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
A cognitive test of processing speed
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
|
Functional testing 3: Timed 25-Foot walk test
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
A test of gait
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
|
Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29)
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
An assessment of how MS impacts a person's function
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
|
Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
An assessment of how fatigue impacts a person's function
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
|
Transcranial Magnetic Stimulation (TMS)
Tidsram: Baseline, 1- and 5- weeks after the final AIH treatment session
|
TMS uses a magnetic coil placed over the scalp to stimulate cortical neurons on the surface of the brain to elicit a motor evoked potential (MEP).
The amount of stimulator output required to obtain a MEP is an indicator of the level of excitability of the neurons; lower threshold indicating greater excitability AIH may decrease inhibition and increase excitation; mechanisms necessary when recovering from neurological injuries.
|
Baseline, 1- and 5- weeks after the final AIH treatment session
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 augusti 2028
Avslutad studie (Beräknad)
1 augusti 2028
Studieregistreringsdatum
Först inskickad
13 maj 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Bio 4476
- LOxyMS USASK -0924 (Annan identifierare: University of Saskatchewan)
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