Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients

NCT ID: NCT03300063

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2020-12-01

Brief Summary

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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

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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

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Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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control

Standard Medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Flow Nocturnal Oxygen

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

Group Type ACTIVE_COMPARATOR

Low flow nocturnal oxygen

Intervention Type OTHER

Nocturnal low-flow oxygen via nasal cannula

Interventions

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Low flow nocturnal oxygen

Nocturnal low-flow oxygen via nasal cannula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients presenting to Mayo Clinic Hospital with acute ischemic stroke
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Melissa Lipford

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa C Lipford

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-002975

Identifier Type: -

Identifier Source: org_study_id

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