Subarachnoid HemorrhageNCT02724215
Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Sleep Apnea, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Sleep Apnea
- What is being tested?
- Sleep Apnea Screening (Out of Center Polysomnography Device)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Mar 2019
- 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 with Subarachnoid Hemorrhage admitted to a University Hospital
Who may be able to join
- Subarachnoid Hemorrhage (Hunt \& Hess 1 to 4)
- > 18 years of age
- Ability to consent for study of healthcare proxy able to confirm patient will to participate
Who cannot join
- Stoke within 3 month prior to admission
- Intubation prior or within 24 hours after admission
- no healthcare proxy
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
In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH.
Read the detailed description
Patients admitted with non-traumatic SAH will be consented and screened for sleep apnea within 48 hours after hospital admission. Blood pressure and clinical outcome will be monitored throughout ICU treatment and hospital stay, respectively. Diagnosis of sleep apnea will be confirmed on follow-up 3-6 month after SAH by sleep apnea screening (portable cardiorespiratory monitoring and out-of-center polysomnography, respectively).
- Conditions
- Subarachnoid Hemorrhage, Sleep Apnea
- Being tested
- Sleep Apnea Screening (Out of Center Polysomnography Device)
- Keywords
- Subarachnoid hemorrhage, Sleep Apnea
- Medical subject headings
- Subarachnoid Hemorrhage, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Apnea Screening (Out of Center Polysomnography Device)Device
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sleep Apnea | Patients with increased apnea-hypopnea-index (>5/h) Receives: Device: Sleep Apnea Screening (Out of Center Polysomnography Device) | |
| Patients without Sleep Apnea | Patients with normal apnea-hypopnea-index (5/h and below) Receives: Device: Sleep Apnea Screening (Out of Center Polysomnography Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to blood pressure target
The time required to reach blood pressure target as defined by care provider.
Measured: Within 10 Days of hospital admission with subarachnoid hemorrhage
Medication needed to achieve blood pressure target
Blood pressure medication required to reach blood pressure target as defined by care provider.
Measured: Within 10 Days of hospital admission with subarachnoid hemorrhage
Secondary outcomes (3)
Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.
Change in modified ranking scale at hospital discharge and at follow-up (3-6 month after SAH) will be assessed and compared between patients with and without sleep apnea. The change from baseline to discharge/follow-up will be compared between groups.
Measured: 3 to 6 Month after SAH
Change in NIH stroke scale score (NIHSS) from admission to discharge and follow-up visit, respectively.
Neurological outcome measured as score in NIHSS at hospital discharge and at follow-up (3-6 month after SAH) will be assessed and compared between patients with and without sleep apnea. The change from baseline to discharge/follow-up will be compared between groups.
Measured: 3 to 6 Month after SAH
Barthel Index at discharge at follow-up visit, respectively.
Impairment of daily living (score in Barthel index) at discharge and at follow-up visit (3 to 6 month after SAH) will be assessed. The change from baseline to discharge/follow-up will be compared between groups.
Measured: 3 to 6 Month after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (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 Subarachnoid HemorrhageStudies 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, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724215
- Sponsor's protocol ID
- 025/16
- Status last verified
- Oct 2017
- First submitted
- 1 Mar 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zaremba S, Albus L, Vatter H, Klockgether T, Guresir E. Poor blood pressure control following subarachnoid hemorrhage in patients with sleep apnea. Sleep Breath. 2021 Jun;25(2):777-785. doi: 10.1007/s11325-020-02184-0. Epub 2020 Sep 14.
PubMed 32926343
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
- Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02724215
- Acronym / sponsor ID
- 025/16
- Conditions
- Subarachnoid Hemorrhage, Sleep Apnea
- Keywords
- Subarachnoid hemorrhage, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 31 Mar 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.
In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH.
Detailed description
Patients admitted with non-traumatic SAH will be consented and screened for sleep apnea within 48 hours after hospital admission. Blood pressure and clinical outcome will be monitored throughout ICU treatment and hospital stay, respectively. Diagnosis of sleep apnea will be confirmed on follow-up 3-6 month after SAH by sleep apnea screening (portable cardiorespiratory monitoring and out-of-center polysomnography, respectively).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Sleep Apnea | – | Device: Sleep Apnea Screening (Out of Center Polysomnography Device)Patients with increased apnea-hypopnea-index (>5/h) |
| Patients without Sleep Apnea | – | Device: Sleep Apnea Screening (Out of Center Polysomnography Device)Patients with normal apnea-hypopnea-index (5/h and below) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Subarachnoid Hemorrhage admitted to a University Hospital
Key inclusion criteria (3 listed)
- Subarachnoid Hemorrhage (Hunt \& Hess 1 to 4)
- > 18 years of age
- Ability to consent for study of healthcare proxy able to confirm patient will to participate
Key exclusion criteria (3 listed)
- Stoke within 3 month prior to admission
- Intubation prior or within 24 hours after admission
- no healthcare proxy
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 |
|---|---|---|
| Sleep Apnea Screening (Out of Center Polysomnography Device) | Device | Patients with Sleep Apnea, Patients without Sleep Apnea |
Primary outcome
Time to blood pressure target
Time frame: Within 10 Days of hospital admission with subarachnoid hemorrhage
The time required to reach blood pressure target as defined by care provider.
Medication needed to achieve blood pressure target
Time frame: Within 10 Days of hospital admission with subarachnoid hemorrhage
Blood pressure medication required to reach blood pressure target as defined by care provider.
3 secondary outcomes
Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.
Time frame: 3 to 6 Month after SAH
Change in NIH stroke scale score (NIHSS) from admission to discharge and follow-up visit, respectively.
Time frame: 3 to 6 Month after SAH
Barthel Index at discharge at follow-up visit, respectively.
Time frame: 3 to 6 Month after SAH
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 32926343Zaremba S, Albus L, Vatter H, Klockgether T, Guresir E. Poor blood pressure control following subarachnoid hemorrhage in patients with sleep apnea. Sleep Breath. 2021 Jun;25(2):777-785. doi: 10.1007/s11325-020-02184-0. Epub 2020 Sep 14.
- Individual participant dataSharing planned: No
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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
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 Subarachnoid Hemorrhage and Sleep Apnea, 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 3 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, sebastian.zaremba@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to blood pressure target (time frame: Within 10 Days of hospital admission with subarachnoid hemorrhage). 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 NCT02724215, 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.