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Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage

NCT ID: NCT02724215

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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

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Subarachnoid Hemorrhage Sleep Apnea

Keywords

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Subarachnoid hemorrhage Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Sleep Apnea

Patients with increased apnea-hypopnea-index (\>5/h)

Sleep Apnea Screening (Out of Center Polysomnography Device)

Intervention Type DEVICE

Patients without Sleep Apnea

Patients with normal apnea-hypopnea-index (5/h and below)

Sleep Apnea Screening (Out of Center Polysomnography Device)

Intervention Type DEVICE

Interventions

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Sleep Apnea Screening (Out of Center Polysomnography Device)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Stoke within 3 month prior to admission
* Intubation prior or within 24 hours after admission
* no healthcare proxy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Zaremba

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdem Gueresir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vice Chair of Department of Neurosurgery

Sebastian Zaremba, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

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Department of Neurology and Department of Neurosurgery

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sebastian Zaremba, MD

Role: CONTACT

Phone: +49(0)228-287-16566

Email: [email protected]

Erdem Gueresir, MD, PhD

Role: CONTACT

Phone: +49(0)228-287-16566

Email: [email protected]

Facility Contacts

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Sebastian Zaremba, MD

Role: primary

Erdem Gueresir, MD, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 32926343 (View on PubMed)

Other Identifiers

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025/16

Identifier Type: -

Identifier Source: org_study_id