Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-002975
NCT ID: NCT03300063
Sponsor Protocol Number: 17-002975
About this 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Eligible patients presenting to Mayo Clinic Hospital – Saint Marys campus with acute stroke will be enrolled.
- Diagnosis of acute stroke (symptoms within 72 hours of admission).
- Informed consent from patient or legal proxy.
- Age ≥ 18 years or older.
- Baseline Oximetry from HSAT ODI ≥15.
- Anticipated hospital stay ≥ 3 days.
Exclusion Criteria:
- Diagnosis of TIA.
- Suspected seizure or other alternate cause of stroke-like symptoms (hemiplegic migraine).
- Respiratory failure requiring mechanical intubation or tracheostomy.
- Current or previous use of CPAP therapy within six months of enrollment, or sustained O2 therapy (other than O2 therapy in an ambulance or emergency department setting).
- Obstructive or restrictive lung disease with O2 dependency.
- Pregnancy.
- Anemia, necessitating blood transfusion.
- Neuromuscular disease with respiratory involvement (amyotrophic lateral sclerosis).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Melissa Lipford, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available