Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h)IESANCT02880059
Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms
An observational study of Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h) and Intracranial Aneurysm Size, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h), Intracranial Aneurysm Size, Blood Pressure Medication
- What is being tested?
- Cardiorepiratory Polygraphy
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18yrs. and older with intracerebral aneurysm.
Who may be able to join
- Intracerebral aneurysm
- Age >= 18yrs.
- Ability to give informed consent
Who cannot join
- Stroke within 3 month of study inclusion.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology and Department of Neurosurgery
Bonn, D-53105
Sebastian Zaremba, MD, +49-228-287-16566, sebastian.zaremba@ukb.uni-bonn.de
Erdem Gueresir, MD, PhD, +49-228-287-16566, erden.güresir@ukb.uni-bonn.de
About this study
Official title: Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms - IESA-Study
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.
Read the 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.
- Conditions
- Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h), Intracranial Aneurysm Size, Blood Pressure Medication, Comorbidities, Complications (Subarachnoid Hemorrhage)
- Being tested
- Cardiorepiratory Polygraphy
- Keywords
- Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.
- Medical subject headings
- Sleep Apnea Syndromes, Subarachnoid Hemorrhage, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorepiratory PolygraphyDevice
Also called Sleep Apnea Screening
Sleep apnea screening by out-of-center polysomnography/polygraphy
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure medication
Blood pressure medication at baseline will be accessed.
Measured: Baseline
Blood pressure
Blood pressure on baseline visit will be accessed.
Measured: Baseline
Secondary outcomes (3)
Subarachnoid hemorrhage
Rate of aneurysm rupture and subarachnoid hemorrhage will be accessed annually.
Measured: 5 years
Increase in size of aneurysm
Measured: 5 years
Change in blood pressure medication
Blood pressure medication will be accessed on annual follow-up for up to 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Zaremba, University Hospital, Bonn
- Investigators
- Erdem Gueresir, MD, PhD, Principal investigator, Vice Chair of Department of NeurosurgerySebastian Zaremba, MD, Principal investigator, Staff Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880059
- Sponsor's protocol ID
- IESA-Study
- Acronym
- IESA
- Status last verified
- Oct 2017
- First submitted
- 23 Aug 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35088709
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms - IESA-Study
- ClinicalTrials.gov ID
- NCT02880059
- Acronym / sponsor ID
- IESA / IESA-Study
- Conditions
- Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h), Intracranial Aneurysm Size, Blood Pressure Medication, Comorbidities, Complications (Subarachnoid Hemorrhage)
- Keywords
- Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18yrs. and older with intracerebral aneurysm.
Key inclusion criteria (3 listed)
- Intracerebral aneurysm
- Age >= 18yrs.
- Ability to give informed consent
Key exclusion criteria (1 listed)
- Stroke within 3 month of study inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorepiratory PolygraphyAlso: Sleep Apnea ScreeningSleep apnea screening by out-of-center polysomnography/polygraphy | Device | – |
Primary outcome
Blood pressure medication
Time frame: Baseline
Blood pressure medication at baseline will be accessed.
Blood pressure
Time frame: Baseline
Blood pressure on baseline visit will be accessed.
3 secondary outcomes
Subarachnoid hemorrhage
Time frame: 5 years
Increase in size of aneurysm
Time frame: 5 years
Change in blood pressure medication
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 35088709Zaremba 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem Gueresir, MD, PhD principal investigator
Vice Chair of Department of Neurosurgery
Sebastian Zaremba, MD principal investigator
Staff Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h) and Intracranial Aneurysm Size, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Zaremba, MD (+49(0)228-287-16566, zaremba.sebastian@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure medication (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.