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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02724215
Enrollment
200
Registered
2016-03-31
Start date
2016-03-31
Completion date
2019-03-31
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhage, Sleep Apnea

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).

Interventions

DEVICESleep Apnea Screening (Out of Center Polysomnography Device)

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to blood pressure targetWithin 10 Days of hospital admission with subarachnoid hemorrhageThe time required to reach blood pressure target as defined by care provider.
Medication needed to achieve blood pressure targetWithin 10 Days of hospital admission with subarachnoid hemorrhageBlood pressure medication required to reach blood pressure target as defined by care provider.

Secondary

MeasureTime frameDescription
Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.3 to 6 Month after SAHChange 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 SAHNeurological 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 SAHImpairment 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.

Other

MeasureTime frame
Incidence of Sleep Apnea in Patients with Subarachnoid Hemorrhage6 Month after SAH

Countries

Germany

Contacts

Primary ContactSebastian Zaremba, MD
sebastian.zaremba@ukb.uni-bonn.de+49(0)228-287-16566
Backup ContactErdem Gueresir, MD, PhD
erdem.gueresir@ukb.uni-bonn.de+49(0)228-287-16566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026