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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01321229
First received: March 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition
Sleep Apnea, Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the variation of the FIM (Functional Independence Measure) [ Time Frame: at 2 months ] [ Designated as safety issue: No ]
    defined by the FIM score after 2 months minus the FIM score at the initial moment(T0)


Secondary Outcome Measures:
  • age [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • BMI (Body Mass Index) [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Score NIHSS (National Institute of Health Stroke Score) [ Time Frame: at 2 months ] [ Designated as safety issue: No ]
    Comparison between inclusion and 2 months

  • Fugl Meyer Assessment of Motor Recovery after Stroke [ Time Frame: at 2 months ] [ Designated as safety issue: No ]
    comparison between inclusion and 2 months

  • Epworth Sleepiness Scale (ESS) [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Attention tests [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    BAWL Test (Batterie Attentionnelle William Lennox)


Estimated Enrollment: 45
Study Start Date: April 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321229

Contacts
Contact: Alain YELNIK, MD,PhD 33 1-40-05-42-05 alain.yelnik@lrb.aphp.fr

Locations
France
PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK Recruiting
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alain YELNIK, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Eric VICAUT, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT01321229     History of Changes
Other Study ID Numbers: UC0902
Study First Received: March 22, 2011
Last Updated: March 22, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sleep apnea
NIHSS scale
FIM scale
FUGL-MEYER scale

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013