Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms

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

• Registration Number: NCT02880059
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2018-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Stroke within 3 month of study inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure medication	Baseline	Blood pressure medication at baseline will be accessed.
Blood pressure	Baseline	Blood pressure on baseline visit will be accessed.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurology and Department of Neurosurgery; 🇩🇪 Bonn, Germany