Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms

Comorbidities Clinical Trial

— IESA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880059
• Other study ID #: IESA-Study
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2016
• Last updated: October 29, 2017
• Start date: June 2016
• Est. completion date: June 2021

Study information

• Verified date: October 2017
• Source: University Hospital, Bonn
• Contact: Sebastian Zaremba, MD
• Phone: +49(0)228-287-16566
• Email: zaremba.sebastian[@]gmx.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2021
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intracerebral aneurysm

• Age >= 18yrs.

• Ability to give informed consent

Exclusion Criteria:

• Stroke within 3 month of study inclusion.

Related Conditions & MeSH terms

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

Intervention

Device:
• Cardiorepiratory Polygraphy
Sleep apnea screening by out-of-center polysomnography/polygraphy

Locations

Country	Name	City	State
Germany	Department of Neurology and Department of Neurosurgery	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure medication	Blood pressure medication at baseline will be accessed.	Baseline
Primary	Blood pressure	Blood pressure on baseline visit will be accessed.	Baseline
Secondary	Subarachnoid hemorrhage	Rate of aneurysm rupture and subarachnoid hemorrhage will be accessed annually.	5 years
Secondary	Increase in size of aneurysm		5 years
Secondary	Change in blood pressure medication	Blood pressure medication will be accessed on annual follow-up for up to 5 years.	5 years