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Ischaemic Stroke and Sleep Apnea in Northern Part of Finland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01861275
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In prospective study the investigators want to know how many ischaemic stroke patients have sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.

Condition or disease Intervention/treatment
Sleep Apnoea Cerebral Palsy Device: Nasal CPAP

Detailed Description:
In prospective study the investigators include all over 18 years old patients who came to emergency room for ischaemic stroke. Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have ischaemic stroke and no thrombolysis and 100 study patients who will have thrombolysis. The investigators do sleep registration during hospital staying within 2 days after patients have felt ill.Follow-up registration will be done after 6 months at home.

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 256 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study
Study Start Date : April 2013
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Nasal CPAP
We want to study the nasal-cpap treatment and it`s compliance in sleep apnea patients with ischaemic stroke.
Device: Nasal CPAP
Nasal CPAP treatment for obstructive sleep apnoea
no Nasal CPAP
No nasal-cpap in sleep apnea patients with ischaemic stroke.


Outcome Measures

Primary Outcome Measures :
  1. cerebral palsy events and severity of osa [ Time Frame: from six months to twenty four months ]
    in prospective study outcome measure is severity of osa in 6months follow-up


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
residents of Oulu university hospital area. consecutive patient sampling
Criteria

Inclusion Criteria:

  • over 18 years old patients that have cerebral palsy and are able to participate to the study.

Exclusion Criteria:

  • no co-operation and need for intensive care unit
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861275


Locations
Finland
Oulu university hospital,department of neurology
Oulu, northern Finland, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Tarja Saaresranta, Md PhD University hospital of Turku
More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01861275     History of Changes
Other Study ID Numbers: 36/2013
36/2013 ( Other Identifier: Oulu university hospital )
36/2013 UO ( Other Identifier: Oulu university hospital )
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Write a paper.

Keywords provided by University of Oulu:
osa
cerebral palsy
thrombolysis in cerebral palsy
sleep registration

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Cerebral Palsy
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases