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Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms

NCT ID: NCT02880059

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h) Intracranial Aneurysm Size Blood Pressure Medication Comorbidities Complications (Subarachnoid Hemorrhage)

Keywords

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Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiorepiratory Polygraphy

Sleep apnea screening by out-of-center polysomnography/polygraphy

Intervention Type DEVICE

Other Intervention Names

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Sleep Apnea Screening

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Stroke within 3 month of study inclusion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Zaremba

Dr. med. Sebastian Zaremba

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdem Gueresir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vice Chair of Department of Neurosurgery

Sebastian Zaremba, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Physician

Locations

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Department of Neurology and Department of Neurosurgery

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sebastian Zaremba, MD

Role: CONTACT

Phone: +49(0)228-287-16566

Email: [email protected]

Erdem Guersir, MD, PhD

Role: CONTACT

Phone: +49(0)228-287-16566

Email: [email protected]

Facility Contacts

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Sebastian Zaremba, MD

Role: primary

Erdem Gueresir, MD, PhD

Role: backup

References

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Zaremba S, Albus L, Hadjiathanasiou A, Vatter H, Wullner U, Guresir E. Aneurysm size and blood pressure severity in patients with intracranial aneurysms and sleep apnea. J Clin Sleep Med. 2022 Jun 1;18(6):1539-1545. doi: 10.5664/jcsm.9906.

Reference Type DERIVED
PMID: 35088709 (View on PubMed)

Other Identifiers

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IESA-Study

Identifier Type: -

Identifier Source: org_study_id