Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke (SAHS)

January 6, 2014 updated by: Dongsheng Fan, Peking University

Screening and Treatment of in Sleep Apnea Hypopnea Syndrome（SAHS)Patients With Acute Ischemic Stroke

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）.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In acute state of ischemic stroke，if patients with sleep apnea hypopnea syndrome may need additional respiratory management such bi-level positive airway pressure.We supposed the patients with stroke can take benefit of functional recovery form bi-level positive airway pressure. We choose the patients who suffered ischemic stroke in 48 hours ，then evaluate the respiratory status. Stroke patients who were diagnosed as sleep apnea hypopnea syndrome will accept additional treatment with bi-level positive airway pressure for 7 night（per night 6 hours）.Then the modified Rankin scale score and NIHSS will be recorded at 30 days and 90 days after stroke.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Liping Wang, Doctor
          • Phone Number: 0086-010-13810002694
          • Email: dianer@126.com
        • Principal Investigator:
          • Dongsheng Fan, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bi-level positive airway pressure
bi-level positive airway pressure for 6 hour per night，total 7 days
Device: Bi level positive pressure ventilation
Bi level positive pressure ventilation should be given for subject for 6 hours per night ，total 7 times.
Device: bi-level positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale score
Time Frame: 90 days after symptoms
0-2 Modified Rankin Scale score should be recognized good functional prognosis
90 days after symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Chair: Dongsheng Fan, P, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

November 17, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2694-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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