NCT02029183

Brief Summary

Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment with noninvasive ventilation for patients with acute ischemic stroke should improve the functional prognosis（measuring with 90d modified Rankin score）.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 17, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

November 17, 2013

Last Update Submit

January 6, 2014

Conditions

Ischemic StrokeSleep Apnea Syndrome

Keywords

stroke, SAHS, BiPAP

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale score

    0-2 Modified Rankin Scale score should be recognized good functional prognosis

    90 days after symptoms

Study Arms (1)

bi-level positive airway pressure

EXPERIMENTAL

bi-level positive airway pressure for 6 hour per night，total 7 days

Device: Bi level positive pressure ventilationDevice: bi-level positive airway pressure

Interventions

Bi level positive pressure ventilationDEVICE

Bi level positive pressure ventilation should be given for subject for 6 hours per night ，total 7 times.

bi-level positive airway pressure
bi-level positive airway pressureDEVICE
bi-level positive airway pressure

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ischeic stroke onset within 48 hours , NIHSS:4-15

You may not qualify if:

  • mRs\>2 before onset of enrollment severe hepatic renal insufficiency cancer in reached an advanced stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea SyndromesStrokeSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dongsheng Fan, P

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2013

First Posted

January 7, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

CN(1)