Clinical trial NCT01321229: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep apnea
NIHSS scale
FIM scale
FUGL-MEYER scale
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: the variation of the FIM (Functional Independence Measure)
timeFrame: at 2 months
Secondary outcomes:
measure: age
timeFrame: at inclusion
measure: BMI (Body Mass Index)
timeFrame: at inclusion
measure: Score NIHSS (National Institute of Health Stroke Score)
timeFrame: at 2 months
measure: Fugl Meyer Assessment of Motor Recovery after Stroke
timeFrame: at 2 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: at inclusion
measure: Attention tests
timeFrame: at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain YELNIK, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: