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

October 29, 2017 updated by: Sebastian Zaremba, University Hospital, Bonn
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, D-53105
        • Recruiting
        • Department of Neurology and Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Subarachnoid Hemorrhage admitted to a University Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of Sleep Apnea in Patients with Subarachnoid Hemorrhage
Time Frame: 6 Month after SAH
6 Month after SAH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Sebastian Zaremba, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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