Back to resultsTreating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
Primary Purpose
Stroke, Acute
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low flow nocturnal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control
Low Flow Nocturnal Oxygen
Arm Description
Standard Medical care
This group will receive standard medical care as well as low flow oxygen during sleep.
Outcomes
Primary Outcome Measures
Modified Rankin Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03300063
Brief Title
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
Official Title
Effects of Treating Sleep Apnea-Induced Hypoxemia With Low-Flow Oxygen in Acute Stroke Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Standard Medical care
Arm Title
Low Flow Nocturnal Oxygen
Arm Type
Active Comparator
Arm Description
This group will receive standard medical care as well as low flow oxygen during sleep.
Intervention Type
Other
Intervention Name(s)
Low flow nocturnal oxygen
Intervention Description
Nocturnal low-flow oxygen via nasal cannula
Primary Outcome Measure Information:
Title
Modified Rankin Score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa C Lipford
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients
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