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The Influence of the Sleep Apnea on the Neurological and Functional Recovery (SAS-AVC)

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ClinicalTrials.gov Identifier: NCT01321229
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date March 22, 2011
First Posted Date March 23, 2011
Last Update Posted Date December 13, 2016
Study Start Date April 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2011)
the variation of the FIM (Functional Independence Measure) [ Time Frame: at 2 months ]
defined by the FIM score after 2 months minus the FIM score at the initial moment(T0)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01321229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 22, 2011)
  • age [ Time Frame: at inclusion ]
  • BMI (Body Mass Index) [ Time Frame: at inclusion ]
  • Score NIHSS (National Institute of Health Stroke Score) [ Time Frame: at 2 months ]
    Comparison between inclusion and 2 months
  • Fugl Meyer Assessment of Motor Recovery after Stroke [ Time Frame: at 2 months ]
    comparison between inclusion and 2 months
  • Epworth Sleepiness Scale (ESS) [ Time Frame: at inclusion ]
  • Attention tests [ Time Frame: at inclusion ]
    BAWL Test (Batterie Attentionnelle William Lennox)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Influence of the Sleep Apnea on the Neurological and Functional Recovery
Official Title Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit
Brief Summary The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.
Detailed Description

The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

Forty-five patients with the average of 58,2 years had been included in this prospective MONOCENTRICAL study. The detection of the sleep respiratory troubles was realised using a nocturnal oxymetry device and measuring the inspiratory flow, gathering the index of apnea-hypopnea.

The NIHSS, the FIM and the FUGL-MEYER scales were used at the moment of inclusion and two months AFTERWORDS.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with stroke history in the past 6 months (ischemic or hemorrhagic) and Hospitalisation in PRM department and participation to a rehabilitation program during study
Condition Sleep Apnea, Obstructive
Intervention Not Provided
Study Groups/Cohorts
  • With sleep APNEA
    Sleeping Apnea Syndrome (SAS) screening usin an APNEA LINK device within the 10 first days following the admission Diagnosis and medical care by a sleeping disorder qualified specialist
  • Without sleep APNEA
    Sleeping Apnea Syndrome (SAS) screening usin an APNEA LINK device within the 10 first days following the admission
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2011)
45
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patient's or one family member's agreement for participation in the study Being aged over 18 years Stroke history in the past 6 months (ischemic or hemorrhagic) Hospitalisation in PRM department and participation to a rehabilitation program during study Patient belonging to the social security system

Exclusion Criteria:

Patient having a sleep apnea syndrome known prior to inclusion Patient presenting a cardiorespiratory INSUFIENCY Patients being INABLE to carry-out the tests or presenting a mental disorder Patients who started already their rehabilitation program before in another PRM center or department

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01321229
Other Study ID Numbers UC0902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Alain YELNIK, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2012