NCT00368628

Brief Summary

New stroke therapies are needed. This study seeks to provide the preliminary data needed to plan a future study that will evaluate the efficacy of using continuous positive airway pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this therapy to reduce stroke symptom severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

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

Study Start

First participant enrolled

November 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

3.3 years

First QC Date

August 24, 2006

Last Update Submit

March 2, 2009

Conditions

Acute Ischemic StrokeSleep Apnea

Keywords

acute ischemic strokesleep apneacontinuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

  • proportion using CPAP within 48-hours of stroke onset

    72 hours

Secondary Outcomes (1)

  • prevalence of sleep apnea

    30 days post stroke

Interventions

continuous positive airway pressurePROCEDURE

Continuous Positive Airway Pressure initiated within 48 hours of stroke onset and continued for 90 days.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep. 2011 Sep 1;34(9):1271-7. doi: 10.5665/SLEEP.1254.

    PMID: 21886365DERIVED

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Dawn M Bravata, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

November 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

US(1)