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

Primary Purpose

Ischemic Stroke, Sleep Apnea Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Bi level positive pressure ventilation

bi-level positive airway pressure

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke, SAHS, BiPAP

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking university third hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bi-level positive airway pressure

Arm Description

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

Outcomes

Primary Outcome Measures

Modified Rankin Scale score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02029183

First Posted

November 17, 2013

Last Updated

January 6, 2014

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02029183

Brief Title

Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke

Acronym

SAHS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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）.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Sleep Apnea Syndrome

Keywords

stroke, SAHS, BiPAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bi-level positive airway pressure

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Bi level positive pressure ventilation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

bi-level positive airway pressure

Primary Outcome Measure Information:

Title

Modified Rankin Scale score

Description

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

Time Frame

90 days after symptoms

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongsheng Fan, P

Organizational Affiliation

Peking University Third Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Peking university third hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liping Wang, Doctor

Phone

0086-010-13810002694

dianer@126.com

First Name & Middle Initial & Last Name & Degree

Dongsheng Fan, professor

12. IPD Sharing Statement

Learn more about this trial

Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke

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