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CompletedNCT03300063Updated Jan 25, 2021

Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients

An interventional study of Low flow nocturnal oxygen in Stroke, Acute, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke, Acute

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patients presenting to Mayo Clinic Hospital with acute ischemic stroke

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
6 participants (actual)

Study arms

  • No intervention
    control

    Standard Medical care

  • Active comparator
    Low Flow Nocturnal Oxygen

    This group will receive standard medical care as well as low flow oxygen during sleep.

    Other: Low flow nocturnal oxygen

Interventions

  • OtherLow flow nocturnal oxygen

    Nocturnal low-flow oxygen via nasal cannula

05

What researchers measure

Primary outcomes

  1. Modified Rankin Score

    Time frame: 3 months

06

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03300063
Lead sponsor
Mayo Clinic
Responsible party
Melissa Lipford (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 3, 2017
Start date
Apr 3, 2018
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Last update
Jan 25, 2021

Study contacts

Melissa C Lipford
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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