Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ischaemic Stroke and Sleep Apnea in Northern Part of Finland

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01861275
First received: May 21, 2013
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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 Intervention
Sleep Apnoea
Cerebral Palsy
Device: Nasal CPAP

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • cerebral palsy events and severity of osa [ Time Frame: from six months to twenty four months ] [ Designated as safety issue: No ]
    in prospective study outcome measure is severity of osa in 6months follow-up


Enrollment: 256
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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  36/2013 UO 
Study First Received: May 21, 2013
Last Updated: May 23, 2016
Health Authority: Finland: Ethics Committee
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 07, 2016