Sleep Apnea, ObstructiveSAS-AVCNCT01321229
The Influence of the Sleep Apnea on the Neurological and Functional Recovery
An observational study of Sleep Apnea, Obstructive, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK
Paris, 75010
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, NIHSS scale, FIM scale, FUGL-MEYER scale
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 2 months
Secondary outcomes (6)
age
Measured: at inclusion
BMI (Body Mass Index)
Measured: at inclusion
Score NIHSS (National Institute of Health Stroke Score)
Comparison between inclusion and 2 months
Measured: at 2 months
Fugl Meyer Assessment of Motor Recovery after Stroke
comparison between inclusion and 2 months
Measured: at 2 months
Epworth Sleepiness Scale (ESS)
Measured: at inclusion
Attention tests
BAWL Test (Batterie Attentionnelle William Lennox)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain YELNIK, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321229
- Sponsor's protocol ID
- UC0902
- Acronym
- SAS-AVC
- Status last verified
- Nov 2012
- First submitted
- 22 Mar 2011
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit
- ClinicalTrials.gov ID
- NCT01321229
- Acronym / sponsor ID
- SAS-AVC / UC0902
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, NIHSS scale, FIM scale, FUGL-MEYER scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
age
Time frame: at inclusion
BMI (Body Mass Index)
Time frame: at inclusion
Score NIHSS (National Institute of Health Stroke Score)
Time frame: at 2 months
Fugl Meyer Assessment of Motor Recovery after Stroke
Time frame: at 2 months
Epworth Sleepiness Scale (ESS)
Time frame: at inclusion
Attention tests
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain YELNIK, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the variation of the FIM (Functional Independence Measure) (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.