Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage

Sleep Apnea Clinical Trial

Official title:

Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02724215
• Other study ID #: 025/16
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2016
• Last updated: October 29, 2017
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: October 2017
• Source: University Hospital, Bonn
• Contact: Sebastian Zaremba, MD
• Phone: +49(0)228-287-16566
• Email: sebastian.zaremba[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH.

Description:

Patients admitted with non-traumatic SAH will be consented and screened for sleep apnea within 48 hours after hospital admission. Blood pressure and clinical outcome will be monitored throughout ICU treatment and hospital stay, respectively. Diagnosis of sleep apnea will be confirmed on follow-up 3-6 month after SAH by sleep apnea screening (portable cardiorespiratory monitoring and out-of-center polysomnography, respectively).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subarachnoid Hemorrhage (Hunt & Hess 1 to 4)

• > 18 years of age

• Ability to consent for study of healthcare proxy able to confirm patient will to participate

Exclusion Criteria:

• Stoke within 3 month prior to admission

• Intubation prior or within 24 hours after admission

• no healthcare proxy

Related Conditions & MeSH terms

• Apnea
• Hemorrhage
• Sleep Apnea
• Sleep Apnea Syndromes
• Subarachnoid Hemorrhage

Intervention

Device:
• Sleep Apnea Screening (Out of Center Polysomnography Device)

Locations

Country	Name	City	State
Germany	Department of Neurology and Department of Neurosurgery	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Sleep Apnea in Patients with Subarachnoid Hemorrhage		6 Month after SAH
Primary	Time to blood pressure target	The time required to reach blood pressure target as defined by care provider.	Within 10 Days of hospital admission with subarachnoid hemorrhage
Primary	Medication needed to achieve blood pressure target	Blood pressure medication required to reach blood pressure target as defined by care provider.	Within 10 Days of hospital admission with subarachnoid hemorrhage
Secondary	Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.	Change in modified ranking scale at hospital discharge and at follow-up (3-6 month after SAH) will be assessed and compared between patients with and without sleep apnea. The change from baseline to discharge/follow-up will be compared between groups.	3 to 6 Month after SAH
Secondary	Change in NIH stroke scale score (NIHSS) from admission to discharge and follow-up visit, respectively.	Neurological outcome measured as score in NIHSS at hospital discharge and at follow-up (3-6 month after SAH) will be assessed and compared between patients with and without sleep apnea. The change from baseline to discharge/follow-up will be compared between groups.	3 to 6 Month after SAH
Secondary	Barthel Index at discharge at follow-up visit, respectively.	Impairment of daily living (score in Barthel index) at discharge and at follow-up visit (3 to 6 month after SAH) will be assessed. The change from baseline to discharge/follow-up will be compared between groups.	3 to 6 Month after SAH