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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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

Первичные конечные точки

• SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm [Срок оценки: During the six AIH treatment session in weeks 1-4]

Вторичные конечные точки (7)

• Worsening on a verbal response 9-Item subjective symptom checklist [Срок оценки: During the six AIH treatment sessions in weeks 1-4]
• Functional testing 1: Nine-Hole Peg test [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]
• Functional testing 2: Symbol Digit Modalities Test [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]
• Functional testing 3: Timed 25-Foot walk test [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]
• Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]
• Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]
• Transcranial Magnetic Stimulation (TMS) [Срок оценки: Baseline, 1- and 5- weeks after the final AIH treatment session]

Критерии участия

Критерии включения

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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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07631143 · Bio 4476 · LOxyMS USASK -0924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗