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

Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive

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
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the variation of the FIM (Functional Independence Measure)	defined by the FIM score after 2 months minus the FIM score at the initial moment(T0)	at 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age		at inclusion
BMI (Body Mass Index)		at inclusion
Score NIHSS (National Institute of Health Stroke Score)	Comparison between inclusion and 2 months	at 2 months
Fugl Meyer Assessment of Motor Recovery after Stroke	comparison between inclusion and 2 months	at 2 months
Epworth Sleepiness Scale (ESS)		at inclusion
Attention tests	BAWL Test (Batterie Attentionnelle William Lennox)	at inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alain YELNIK, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Sleep apnea; NIHSS scale; FIM scale; FUGL-MEYER scale
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: UC0902