Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— SAHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029183
• Other study ID #: 2694-01
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2013
• Last updated: January 6, 2014
• Start date: December 2013
• Est. completion date: May 2017

Study information

• Verified date: January 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Stroke

Intervention

Device:
• Bi level positive pressure ventilation
Bi level positive pressure ventilation should be given for subject for 6 hours per night ,total 7 times.
• bi-level positive airway pressure

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale score	0-2 Modified Rankin Scale score should be recognized good functional prognosis	90 days after symptoms	Yes