Sleep ApnoeaNCT01861275
Ischaemic Stroke and Sleep Apnea in Northern Part of Finland
An observational study of Sleep Apnoea and Cerebral Palsy, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnoea, Cerebral Palsy
- What is being tested?
- Nasal CPAP
- Type of treatment
- Medical device
- How many people
- 256 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2013to Jan 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: residents of Oulu university hospital area. consecutive patient sampling
Who may be able to join
- over 18 years old patients that have cerebral palsy and are able to participate to the study.
Who cannot join
- no co-operation and need for intensive care unit
Trial locations and contacts
1 site in 1 country.
Finland1 site
Oulu university hospital,department of neurology
Oulu, Northern Finland, 90029
About this study
Official title: Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study
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.
Read the 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.
- Conditions
- Sleep Apnoea, Cerebral Palsy
- Being tested
- Nasal CPAP
- Keywords
- osa, cerebral palsy, thrombolysis in cerebral palsy, sleep registration
- Medical subject headings
- Sleep Apnea Syndromes, Cerebral Palsy, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CPAPDevice
Nasal CPAP treatment for obstructive sleep apnoea
| Study group | Role | What they receive |
|---|---|---|
| Nasal CPAP | We want to study the nasal-cpap treatment and it's compliance in sleep apnea patients with ischaemic stroke. Receives: Device: Nasal CPAP | |
| no Nasal CPAP | No nasal-cpap in sleep apnea patients with ischaemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral palsy events and severity of osa
in prospective study outcome measure is severity of osa in 6months follow-up
Measured: from six months to twenty four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarja Saaresranta, Md PhD, Study director, University hospital of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861275
- Sponsor's protocol ID
- 36/2013
- Other IDs
- 36/2013, 36/2013 UO
- Status last verified
- May 2016
- First submitted
- 21 May 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Write a paper.
Publications
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.
PubMed 35679775Huhtakangas 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.
PubMed 31751906Huhtakangas 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.
PubMed 30518443Huhtakangas 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.
PubMed 29221777
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study
- ClinicalTrials.gov ID
- NCT01861275
- Acronym / sponsor ID
- 36/2013
- Conditions
- Sleep Apnoea, Cerebral Palsy
- Keywords
- osa, cerebral palsy, thrombolysis in cerebral palsy, sleep registration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal CPAP | – | Device: Nasal CPAPWe want to study the nasal-cpap treatment and it's compliance in sleep apnea patients with ischaemic stroke. |
| no Nasal CPAP | – | –No nasal-cpap in sleep apnea patients with ischaemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of Oulu university hospital area. consecutive patient sampling
Key inclusion criteria (1 listed)
- over 18 years old patients that have cerebral palsy and are able to participate to the study.
Key exclusion criteria (1 listed)
- no co-operation and need for intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal CPAPNasal CPAP treatment for obstructive sleep apnoea | Device | Nasal CPAP |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 35679775Huhtakangas 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.
- Derived from this study: PubMed 31751906Huhtakangas 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.
- Derived from this study: PubMed 30518443Huhtakangas 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.
- Derived from this study: PubMed 29221777Huhtakangas 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.
- Individual participant dataSharing planned: Yes. Write a paper.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarja Saaresranta, Md PhD study director
University hospital of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnoea and Cerebral Palsy, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral palsy events and severity of osa (time frame: from six months to twenty four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01861275, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.