Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms (IESA)

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

Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms - IESA-Study

Patients with intracerebral aneurysm will be screened for sleep apnea using out of center polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and changes in medication.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patient presenting to the outpatient center for neurological of neurosurgical management of intracerebral aneurysm will be recruited. Sleep apnea will be assessed by questionnaire and out of center polygraph/polysomnography. Medication, comorbidities and blood pressure will be recorded. Change in aneurysm size and blood pressure medication will be evaluated annually for up to 5 years. Frequency of subarachnoid hemorrhage and increase in aneurysm size will be assessed.

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 18yrs. and older with intracerebral aneurysm.

Description

Inclusion Criteria:

  • Intracerebral aneurysm
  • Age >= 18yrs.
  • Ability to give informed consent

Exclusion Criteria:

  • Stroke within 3 month of study inclusion.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure medication
Time Frame: Baseline
Blood pressure medication at baseline will be accessed.
Baseline
Blood pressure
Time Frame: Baseline
Blood pressure on baseline visit will be accessed.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subarachnoid hemorrhage
Time Frame: 5 years
Rate of aneurysm rupture and subarachnoid hemorrhage will be accessed annually.
5 years
Increase in size of aneurysm
Time Frame: 5 years
5 years
Change in blood pressure medication
Time Frame: 5 years
Blood pressure medication will be accessed on annual follow-up for up to 5 years.
5 years

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, Staff 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

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (ESTIMATE)

August 26, 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

  • IESA-Study

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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