Incidence and Effects of Sleep Apnea on Intracerebral Ane... | NCT02880059

Studies
Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms

NCT02880059

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Oct 31, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

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

Interventions

Cardiorepiratory Polygraphy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Aug 23, 2016

First Submission Date that Met QC Criteria

Aug 23, 2016

First Posted Date

Aug 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2017

Last Update Posted Date

Oct 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sebastian Zaremba, Dr. med. Sebastian Zaremba, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiorepiratory Polygraphy	Device	Sleep apnea screening by out-of-center polysomnography/polygraphy		Sleep Apnea Screening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Subarachnoid hemorrhage	Rate of aneurysm rupture and subarachnoid hemorrhage will be accessed annually.	5 years
Increase in size of aneurysm		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Stroke within 3 month of study inclusion.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients 18yrs. and older with intracerebral aneurysm.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sebastian Zaremba, MD	Contact	+49(0)228-287-16566		zaremba.sebastian@gmx.net
Erdem Guersir, MD, PhD	Contact	+49(0)228-287-16566		erdem.gueresir@ukb.uni-bonn.de

Overall Officials

Name	Affiliation	Role
Erdem Gueresir, MD, PhD	Vice Chair of Department of Neurosurgery	Principal Investigator
Sebastian Zaremba, MD	Staff Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology and Department of Neurosurgery	Recruiting	Bonn		D-53105	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35088709	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D013345	Subarachnoid Hemorrhage
D000783	Aneurysm

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic