The Influence of the Sleep Apnea on the Neurological and Functional Recovery

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT01321229
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-11
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK; 🇫🇷 Paris, France