Trial record 3 of 282 for:    "Cerebral Palsy"

Cerebral Palsy and Sleep Apnea in North Part of Finland

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01861275
First received: May 21, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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


Condition
Sleep Apnoea
Cerebral Palsy

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 Cerebral Palsy, 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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
cpap

Nasal-cpap treatment and compliance in sleep apnea patients with cerebral palsy.

No Nasal-cpap treatment in sleep apnea patients with cerebral palsy. Severity of sleep apnea in thrombolysis patients and in control patients. Thrombolysis reduces severity of sleep apnea.Sleep apnea is common among cerebral palsy patients.

no cpap
No nasal-cpap in sleep apnea patients with cerebral palsy

Detailed Description:

In prospective study the investigators include all over 18 years old patients who came to emergency room for cerebral palsy.Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have cerebral palsy 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
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

Contacts
Contact: Jaana Huhtakangas, MD +35883154038 jaana.huhtakangas@ppshp.fi
Contact: Juha Huhtakangas, MD, PhD +35883154032 juha.huhtakangas@ppshp.fi

Locations
Finland
Oulu university hospital,department of neurology Recruiting
Oulu, northern Finland, Finland, 90029
Contact: Juha Huhtakangas, Md PhD    +35883154032    juha.huhtakangas@ppshp.fi   
Contact: Jaana huhtakangas, Md    +358083154038    jaana.huhtakangas@ppshp.fi   
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Tarja Saaresranta, Md PhD University hospital of Turku
  More Information

No publications provided

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 22, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014