Skip to main content
OpenTrials
Completed

NCT Number: NCT01321229

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. age

    Time frame: at inclusion

  2. BMI (Body Mass Index)

    Time frame: at inclusion

  3. Score NIHSS (National Institute of Health Stroke Score)

    Time frame: at 2 months

    Comparison between inclusion and 2 months

  4. Fugl Meyer Assessment of Motor Recovery after Stroke

    Time frame: at 2 months

    comparison between inclusion and 2 months

  5. Epworth Sleepiness Scale (ESS)

    Time frame: at inclusion

  6. Attention tests

    Time frame: at inclusion

    BAWL Test (Batterie Attentionnelle William Lennox)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SAS-AVC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2011
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.