Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acu... | NCT03300063

Studies
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients

NCT03300063

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 25, 2021Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Stroke, Acute

Interventions

Low flow nocturnal oxygen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2018Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Oct 2, 2017

First Posted Date

Oct 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Low flow nocturnal oxygen	Other	Nocturnal low-flow oxygen via nasal cannula	Low Flow Nocturnal Oxygen

Measure	Description	Time Frame
Modified Rankin Score		3 months

Eligibility Module

Eligibility Criteria

Patients presenting to Mayo Clinic Hospital with acute ischemic stroke

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa C Lipford	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided