NCT03300063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

August 28, 2017

Last Update Submit

January 22, 2021

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Score

    3 months

Study Arms (2)

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.

Other: Low flow nocturnal oxygen

Interventions

Low flow nocturnal oxygenOTHER

Nocturnal low-flow oxygen via nasal cannula

Low Flow Nocturnal Oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Melissa C Lipford

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

October 3, 2017

Study Start

April 3, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

US(1)