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

Sleep Apnea, Obstructive Clinical Trial

— SAS-AVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321229
• Other study ID #: UC0902
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: December 12, 2016
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	age		at inclusion	No
Secondary	BMI (Body Mass Index)		at inclusion	No
Secondary	Score NIHSS (National Institute of Health Stroke Score)	Comparison between inclusion and 2 months	at 2 months	No
Secondary	Fugl Meyer Assessment of Motor Recovery after Stroke	comparison between inclusion and 2 months	at 2 months	No
Secondary	Epworth Sleepiness Scale (ESS)		at inclusion	No
Secondary	Attention tests	BAWL Test (Batterie Attentionnelle William Lennox)	at inclusion	No