NCT01861275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

May 21, 2013

Last Update Submit

May 23, 2016

Conditions

Keywords

osacerebral palsythrombolysis in cerebral palsysleep registration

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nasal CPAP

We want to study the nasal-cpap treatment and it's compliance in sleep apnea patients with ischaemic stroke.

Device: Nasal CPAP

no Nasal CPAP

No nasal-cpap in sleep apnea patients with ischaemic stroke.

Interventions

Nasal CPAP treatment for obstructive sleep apnoea

Nasal CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

residents of Oulu university hospital area. consecutive patient sampling

You may qualify if:

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

You may not qualify if:

  • no co-operation and need for intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu university hospital,department of neurology

Oulu, Northern Finland, 90029, Finland

Location

Related Publications (4)

  • Huhtakangas JK, Saaresranta T, Vahanikkila H, Huhtakangas J. Nocturnal hypoxemia and central apneas increase mortality, but not recurrent ischemic events after ischemic stroke. Sleep Med. 2022 Sep;97:1-9. doi: 10.1016/j.sleep.2022.05.014. Epub 2022 May 23.

  • Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Unattended sleep study in screening for sleep apnea in the acute phase of ischemic stroke. Sleep Med. 2020 Jan;65:121-126. doi: 10.1016/j.sleep.2019.08.002. Epub 2019 Aug 8.

  • Huhtakangas JK, Saaresranta T, Bloigu R, Huhtakangas J. The Evolution of Sleep Apnea Six Months After Acute Ischemic Stroke and Thrombolysis. J Clin Sleep Med. 2018 Dec 15;14(12):2005-2011. doi: 10.5664/jcsm.7524. Erratum In: J Clin Sleep Med. 2020 May 15;16(5):837-838. doi: 10.5664/jcsm.8428.

  • Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Prevalence of sleep apnea at the acute phase of ischemic stroke with or without thrombolysis. Sleep Med. 2017 Dec;40:40-46. doi: 10.1016/j.sleep.2017.08.018. Epub 2017 Oct 7.

MeSH Terms

Conditions

Sleep Apnea SyndromesCerebral PalsySleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Tarja Saaresranta, Md PhD

    University hospital of Turku

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Write a paper.

Locations