Ischaemic Stroke and Sleep Apnea in Northern Part of Finland

Cerebral Palsy Clinical Trial

Official title:

Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861275
• Other study ID #: 36/2013
• Secondary ID: 36/201336/2013 U
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 23, 2016
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Cerebral Palsy
• Sleep Apnea Syndromes
• Sleep Apnoea

Intervention

Device:
• Nasal CPAP
Nasal CPAP treatment for obstructive sleep apnoea

Locations

Country	Name	City	State
Finland	Oulu university hospital,department of neurology	Oulu	northern Finland

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral palsy events and severity of osa	in prospective study outcome measure is severity of osa in 6months follow-up	from six months to twenty four months	No