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

• Conditions: Subarachnoid Hemorrhage; Sleep Apnea
• Interventions: Device: Sleep Apnea Screening (Out of Center Polysomnography Device)

• Registration Number: NCT02724215
• Lead Sponsor: University Hospital, Bonn

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without Sleep Apnea	Sleep Apnea Screening (Out of Center Polysomnography Device)	Patients with normal apnea-hypopnea-index (5/h and below)
Patients with Sleep Apnea	Sleep Apnea Screening (Out of Center Polysomnography Device)	Patients with increased apnea-hypopnea-index (\>5/h)

Primary Outcome Measures

Name	Time	Method
Time to blood pressure target	Within 10 Days of hospital admission with subarachnoid hemorrhage	The time required to reach blood pressure target as defined by care provider.
Medication needed to achieve blood pressure target	Within 10 Days of hospital admission with subarachnoid hemorrhage	Blood pressure medication required to reach blood pressure target as defined by care provider.

Secondary Outcome Measures

Name	Time	Method
Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.	3 to 6 Month after SAH	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.
Change in NIH stroke scale score (NIHSS) from admission to discharge and follow-up visit, respectively.	3 to 6 Month after SAH	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.
Barthel Index at discharge at follow-up visit, respectively.	3 to 6 Month after SAH	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.

Trial Locations

Locations (1)

Department of Neurology and Department of Neurosurgery; 🇩🇪 Bonn, Germany