NCT00282815

Brief Summary

The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 11, 2013

Completed
Last Updated

March 11, 2013

Status Verified

December 1, 2012

Enrollment Period

5.7 years

First QC Date

January 26, 2006

Results QC Date

June 21, 2011

Last Update Submit

January 31, 2013

Conditions

Obstructive Sleep ApneaStroke

Keywords

obstructive sleep apneastrokeOSACPAPcontinuous positive airway pressure

Outcome Measures

Primary Outcomes (2)

  • Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.

    3 months

  • Number of Subjects Who Withdraw From Study.

    Prespecified outcome.

    3 months

Secondary Outcomes (1)

  • Barthel Index

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

CPAP

Device: continuous positive airway pressure or CPAP

2

SHAM COMPARATOR

sham CPAP (placebo)

Device: sham CPAP

Interventions

continuous positive airway pressure or CPAPDEVICE

RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.

1
sham CPAPDEVICE

sham CPAP

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke within 7 days of planned polysomnography/sleep screening study
  • Modified Rankin Scale score \>1
  • If of child-bearing potential, has a negative urine or serum pregnancy test

You may not qualify if:

  • Decompensated heart failure
  • Cardiac or respiratory arrest within the past 3 months
  • Myocardial infarction within the past 3 months
  • Severe pneumonia
  • Hypertension refractory to treatment
  • Any other unstable medical condition which is thought to interfere with participation
  • Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP
  • Previous pneumothorax
  • Bullous emphysema
  • Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP
  • Acute sinus or ear infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23.

    PMID: 21784661RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveStroke

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Limitations and Caveats

Attrition pre-randomization and while in randomized treatment led to small numbers.

Results Point of Contact

Title
Devin Brown, MD
Organization
University of Michigan
devinb@umich.edu
734-936-9075

Study Officials

  • Devin Brown, MD, MS

    Associate Professor, Stroke Program, University of Michigan

    PRINCIPAL INVESTIGATOR

  • Lewis Morgenstern, MD

    Director, Stroke Program, University of Michigan

    STUDY DIRECTOR

  • Jack Kalbfleisch, PhD

    University of Michigan Dept of Biostatistics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

September 1, 2004

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 11, 2013

Results First Posted

March 11, 2013

Record last verified: 2012-12

Locations

US(1)