Multiple Sclerosis, Relapsing-RemittingNCT04280484
Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
A study testing Intermittent Hypoxia in people with Multiple Sclerosis, Relapsing-Remitting, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Intermittent Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have relapsing-remitting MS
- Volitional ankle plantar flexion strength in at least one leg
- Are relapse free for 30 days
- Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)
Who cannot join
- Currently taking antispasticity medications,
- Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
- Pregnant or nursing women (safety for developing fetus or infant is unknown)
- Cognitive concerns (must be able to consent to study, follow steps)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Intermittent Hypoxia, Sham Hypoxia
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent HypoxiaOther
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Sham HypoxiaOther
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
| Study group | Role | What they receive |
|---|---|---|
| Acute Intermittent Hypoxia | Experimental | 1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts Receives: Other: Intermittent Hypoxia |
| Sham Acute Intermittent Hypoxia | Sham comparator | 1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts. Receives: Other: Sham Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary Ankle Strength
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
Measured: 60 minutes post-intervention
Secondary outcomes (2)
Electromyogram activity
Plantar-flexor and Dorsi-flexor electromyogram activity
Measured: 60 minutes post-intervention
Symbol Digit Modalities Test
The symbol-digit modalities test (SDMT) is a symbol substitution neuropsychological test that examines a person's attention and speed of processing
Measured: 60 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start18 Jun 2018
- Primary completion10 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Hines Jr. VA Hospital
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280484
- Sponsor's protocol ID
- STU00207024
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04280484
- Acronym / sponsor ID
- STU00207024
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Edward Hines Jr. VA Hospital
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Intermittent Hypoxia | Experimental | Other: Intermittent Hypoxia1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts |
| Sham Acute Intermittent Hypoxia | Sham comparator | Other: Sham Hypoxia1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have relapsing-remitting MS
- Volitional ankle plantar flexion strength in at least one leg
- Are relapse free for 30 days
- Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)
Key exclusion criteria (4 listed)
- Currently taking antispasticity medications,
- Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
- Pregnant or nursing women (safety for developing fetus or infant is unknown)
- Cognitive concerns (must be able to consent to study, follow steps)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Hypoxia1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes. | Other | Acute Intermittent Hypoxia |
| Sham Hypoxia1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes. | Other | Sham Acute Intermittent Hypoxia |
Primary outcome
Voluntary Ankle Strength
Time frame: 60 minutes post-intervention
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
2 secondary outcomes
Electromyogram activity
Time frame: 60 minutes post-intervention
Symbol Digit Modalities Test
Time frame: 60 minutes post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia in people with Multiple Sclerosis, Relapsing-Remitting, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary Ankle Strength (time frame: 60 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.