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Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure

NCT ID: NCT01446913

Last Updated: 2020-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-04-30

Brief Summary

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The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.

Detailed Description

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The proposed study is a randomized controlled trial among patients with transient ischemic attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2 (control:intervention) randomization scheme. Intervention patients with sleep apnea will receive either a standard CPAP treatment intervention or an enhanced protocol designed to increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) CPAP adherence.

Conditions

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Transient Ischemic Attack Stroke

Keywords

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Sleep Apnea CPAP adherence behavioral adherence stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard Intervention group

This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.

Group Type ACTIVE_COMPARATOR

Standard CPAP Intervention

Intervention Type DEVICE

Enhanced CPAP intervention

This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.

Group Type ACTIVE_COMPARATOR

Enhanced CPAP Intervention

Intervention Type BEHAVIORAL

Usual Care

This group usual care after TIA/stroke and a sleep study at the end of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard CPAP Intervention

Intervention Type DEVICE

Enhanced CPAP Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* TIA or ischemic stroke
* within 1 week of neurological symptom onset
* brain imaging within 24 hours

Exclusion Criteria

* known to have sleep apnea
* suspected sleep disorder other than sleep apnea
* hospice patients or patients receiving comfort only measures
* patients unable to use a nasal or face mask
* patients who require mechanical ventilation
* Non English language patients
* inability to provide informed consent
* active suicidal ideation
* live outside the recruitment area
* provider does not allow researcher to contact patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry Yaggi, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Dawn M Bravata, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

University of Indiana

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Koo BB, Bravata DM, Tobias LA, Mackey JS, Miech EJ, Matthias MS, Stahl SM, Sico JJ, Vaz Fragoso CA, Williams LS, Lampert R, Qin L, Yaggi HK. Observational Study of Obstructive Sleep Apnea in Wake-Up Stroke: The SLEEP TIGHT Study. Cerebrovasc Dis. 2016;41(5-6):233-41. doi: 10.1159/000440736. Epub 2016 Jan 27.

Reference Type BACKGROUND
PMID: 26811929 (View on PubMed)

Yaggi HK, Mittleman MA, Bravata DM, Concato J, Ware J, Stoney CM, Redline S. Reducing cardiovascular risk through treatment of obstructive sleep apnea: 2 methodological approaches. Am Heart J. 2016 Feb;172:135-43. doi: 10.1016/j.ahj.2015.07.033. Epub 2015 Sep 11.

Reference Type DERIVED
PMID: 26856225 (View on PubMed)

Other Identifiers

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U34HL105285-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1101007811

Identifier Type: -

Identifier Source: org_study_id