NCT02880059

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

August 23, 2016

Last Update Submit

October 29, 2017

Conditions

Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h)Intracranial Aneurysm SizeBlood Pressure MedicationComorbiditiesComplications (Subarachnoid Hemorrhage)

Keywords

Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.

Outcome Measures

Primary Outcomes (2)

  • Blood pressure medication

    Blood pressure medication at baseline will be accessed.

    Baseline

  • Blood pressure

    Blood pressure on baseline visit will be accessed.

    Baseline

Secondary Outcomes (3)

  • Subarachnoid hemorrhage

    5 years

  • Increase in size of aneurysm

    5 years

  • Change in blood pressure medication

    5 years

Interventions

Cardiorepiratory PolygraphyDEVICE

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

Also known as: Sleep Apnea Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18yrs. and older with intracerebral aneurysm.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology and Department of Neurosurgery

Bonn, D-53105, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35088709DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSubarachnoid HemorrhageAneurysm

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Erdem Gueresir, MD, PhD

    Vice Chair of Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

  • Sebastian Zaremba, MD

    Staff Physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Zaremba, MD

CONTACT

+49(0)228-287-16566zaremba.sebastian@gmx.net

Erdem Guersir, MD, PhD

CONTACT

+49(0)228-287-16566erdem.gueresir@ukb.uni-bonn.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Sebastian Zaremba

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2021

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)