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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01321229
First received: March 22, 2011
Last updated: December 12, 2016
Last verified: November 2012
  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:


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 ]
    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 ]
  • 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)


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01321229

Locations
France
PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK
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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01321229     History of Changes
Other Study ID Numbers: UC0902
Study First Received: March 22, 2011
Last Updated: December 12, 2016

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 Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 25, 2017