Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke

Not Applicable

• Conditions: Ischemic Stroke; Sleep Apnea Syndrome
• Interventions: Device: Bi level positive pressure ventilation; Device: bi-level positive airway pressure

• Registration Number: NCT02029183
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2013-11-17
• Study Start: 2013-12
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-06
• Last Update Submitted: 2014-01-06
• Study First Posted: 2014-01-07
• Last Update Posted: 2014-01-07
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bi-level positive airway pressure	Bi level positive pressure ventilation	bi-level positive airway pressure for 6 hour per night，total 7 days
bi-level positive airway pressure	bi-level positive airway pressure	bi-level positive airway pressure for 6 hour per night，total 7 days

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	90 days after symptoms	0-2 Modified Rankin Scale score should be recognized good functional prognosis

Trial Locations

Locations (1)

Peking university third hospital; 🇨🇳 Beijing, Beijing, China