Stroke, AcuteNCT03300063
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
A study testing Low flow nocturnal oxygen in people with Stroke, Acute, run by Mayo Clinic at 1 site in United States.
Trial summary
We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Low flow nocturnal oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study
We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.
Read the detailed description
Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those with evidence of hypoxemia will be randomized into two groups. One group will receive standard medical care. The other group will receive standard medical care as well as receiving low flow oxygen during sleep.
- Conditions
- Stroke, Acute
- Being tested
- Low flow nocturnal oxygen
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow nocturnal oxygenOther
Nocturnal low-flow oxygen via nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Standard Medical care |
| Low Flow Nocturnal Oxygen | Active comparator | This group will receive standard medical care as well as low flow oxygen during sleep. Receives: Other: Low flow nocturnal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start3 Apr 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Lipford, Mayo Clinic
- Investigators
- Melissa C Lipford, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300063
- Sponsor's protocol ID
- 17-002975
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2017
- Last updated
- 25 Jan 2021
- 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03300063
- Acronym / sponsor ID
- 17-002975
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 3 Oct 2017 (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.
We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.
Detailed description
Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those with evidence of hypoxemia will be randomized into two groups. One group will receive standard medical care. The other group will receive standard medical care as well as receiving low flow oxygen during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Standard Medical care |
| Low Flow Nocturnal Oxygen | Active comparator | Other: Low flow nocturnal oxygenThis group will receive standard medical care as well as low flow oxygen during sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Low flow nocturnal oxygenNocturnal low-flow oxygen via nasal cannula | Other | Low Flow Nocturnal Oxygen |
Primary outcome
Modified Rankin Score
Time frame: 3 months
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 25 Jan 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Melissa C Lipford principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow nocturnal oxygen in people with Stroke, Acute, run by Mayo Clinic 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?
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 25 Jan 2021. 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. 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?
Modified Rankin Score (time frame: 3 months). 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 25 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.