Obstructive Sleep Apnea SyndromeNCT01561677
Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.
A study testing Continuous Positive Airway pressure-RESPIRONICS in people with Obstructive Sleep Apnea Syndrome and Brain Infarction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Brain Infarction
- What is being tested?
- Continuous Positive Airway pressure-RESPIRONICS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Dec 2020
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brain infarction confirmed by brain imaging
- follow up possible
- Severity at admission and at one week follow up:
- NIHSS ≥ 4 or- isolated aphasia (item 9 ofNIHSS ≥ 1) or
- negligence (item 11 du NIHSS ≥ 2) or
- distal motor deficit (score ≥ 1)
- Health insurance affiliation
- Inform and free consent agreement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Yves DAUVILLIERS, MD-PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Valérie Cochen De Cock
About this study
Official title: Consequences of Obstructive Sleep Apnea Syndrome (OSAS) on the Outcome and the Survival After Ischemic Subtentorial Stroke. Impact of the Treatment With Continuous Positive Airway Pressure (CPAP)
Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.
Read the detailed description
Objective : The aim of our study is to evaluate the consequences of obstructive sleep apnea syndrome on the functional outcome and the survival after an ischemic stroke and to measure the impact of the treatment with continuous positive airway pressure on the outcome of patients with severe obstructive sleep apnea syndrome.Patients and methods : We will prospectively explore by polysomnography, 300 consecutive patients hospitalized for an ischemic stroke in the stroke units of university hospitals at the sub acute phase after stroke (J15±4). 1) We will compare the functional outcome, the neurological impairment, the peripheral endothelial function, the continuous blood pressure measure on 24 hours recording, the quality of life and the survival at 3, 6 and 12 months in four groups of patients depending on their apnea/hypopnea index 2) In patients with severe obstructive sleep apnea syndrome, we will explore the impact on the functional outcome, the neurological impairment, and the survival at 3, 6 et 12 months of a treatment with continuous positive airway pressure (CPAP) randomly compared to a treatment with sham CPAP (non efficacious pressure) during 3 months. Conclusion : This study should allow us to evaluate the consequences of obstructive sleep apnea syndrome on the outcome and the survival after ischemic stroke and the impact and the tolerance of the treatment with continuous positive airway pressure in patients with severe obstructive sleep apnea syndrome.
- Conditions
- Obstructive Sleep Apnea Syndrome, Brain Infarction
- Being tested
- Continuous Positive Airway pressure-RESPIRONICS, Sham Continuous Positive Airway pressure-RESPIRONICS
- Keywords
- obstructive sleep apnea, syndrome survival, ischemic stroke, continuous positive airway pressure, handicap
- Medical subject headings
- Sleep Apnea, Obstructive, Brain Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway pressure-RESPIRONICSDevice
obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
Sham Continuous Positive Airway pressure-RESPIRONICSDevice
inefficient Continuous Positivie Airway pressure
| Study group | Role | What they receive |
|---|---|---|
| apnea/hypopnea index (AHI<5 : no OSAS) | No intervention | Not described |
| apnea/hypopnea index (5≥AHI<15 : mild OSAS) | No intervention | Not described |
| apnea/hypopnea index (15≤AHI<30 :moderate OSAS) | No intervention | Not described |
| apnea/hypopnea index ( AHI≥30 : severe OSAS treated). | Active comparator | Treated with CPAP Receives: Device: Continuous Positive Airway pressure-RESPIRONICS |
| apnea/hypopnea index ( AHI≥30:severe OSAS untreated). | Sham comparator | Treated with sham CPAP (placebo) Receives: Device: Sham Continuous Positive Airway pressure-RESPIRONICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional independence scale
The variation of the functional independence scale is evaluated by the Barthel Index at three months after stroke in four groups of patients depending on their apnea/hypopnea.In the patients group severe OSAS treated with CPAP from day 15 after stroke compared to patients with severe OSAS treated with sham CPAPThe neurological dependency will be evaluated by the Barthel Index .This scale measures the consequences of the motor and cognitive disorders on the daily living with 10 items.
Measured: 3 months
Secondary outcomes (5)
neurological impairment
The variation of the neurological impairment (NIHSS score) at three months after stroke:
- in four groups of patients depending on their apnea/hypopnea index
- In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
Measured: 3 months
the handicap
the handicap (via the Rankin score ), at three months after stroke:
in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
Measured: 3 months
blood pressure
The continuous measure of blood pressure over 24 hours at three months after stroke:
in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
Measured: 3 months
the quality of life
the quality of life (SF-36) at three months after stroke:
in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
Measured: 3 months
the survival
the survival at three months after stroke:
in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561677
- Sponsor's protocol ID
- 8670
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2012
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Denis C, Jaussent I, Guiraud L, Mestejanot C, Arquizan C, Mourand I, Chenini S, Abril B, Wacongne A, Tamisier R, Baillieul S, Pepin JL, Barateau L, Dauvilliers Y. Functional recovery after ischemic stroke: Impact of different sleep health parameters. J Sleep Res. 2024 Feb;33(1):e13964. doi: 10.1111/jsr.13964. Epub 2023 Jun 20.
PubMed 37338010
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Obstructive Sleep Apnea Syndrome (OSAS) on the Outcome and the Survival After Ischemic Subtentorial Stroke. Impact of the Treatment With Continuous Positive Airway Pressure (CPAP)
- ClinicalTrials.gov ID
- NCT01561677
- Acronym / sponsor ID
- 8670
- Conditions
- Obstructive Sleep Apnea Syndrome, Brain Infarction
- Keywords
- obstructive sleep apnea, syndrome survival, ischemic stroke, continuous positive airway pressure, handicap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Mar 2012 (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.
Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.
Detailed description
Objective : The aim of our study is to evaluate the consequences of obstructive sleep apnea syndrome on the functional outcome and the survival after an ischemic stroke and to measure the impact of the treatment with continuous positive airway pressure on the outcome of patients with severe obstructive sleep apnea syndrome.Patients and methods : We will prospectively explore by polysomnography, 300 consecutive patients hospitalized for an ischemic stroke in the stroke units of university hospitals at the sub acute phase after stroke (J15±4). 1) We will compare the functional outcome, the neurological impairment, the peripheral endothelial function, the continuous blood pressure measure on 24 hours recording, the quality of life and the survival at 3, 6 and 12 months in four groups of patients depending on their apnea/hypopnea index 2) In patients with severe obstructive sleep apnea syndrome, we will explore the impact on the functional outcome, the neurological impairment, and the survival at 3, 6 et 12 months of a treatment with continuous positive airway pressure (CPAP) randomly compared to a treatment with sham CPAP (non efficacious pressure) during 3 months. Conclusion : This study should allow us to evaluate the consequences of obstructive sleep apnea syndrome on the outcome and the survival after ischemic stroke and the impact and the tolerance of the treatment with continuous positive airway pressure in patients with severe obstructive sleep apnea syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| apnea/hypopnea index (AHI<5 : no OSAS) | No intervention | – |
| apnea/hypopnea index (5≥AHI<15 : mild OSAS) | No intervention | – |
| apnea/hypopnea index (15≤AHI<30 :moderate OSAS) | No intervention | – |
| apnea/hypopnea index ( AHI≥30 : severe OSAS treated). | Active comparator | Device: Continuous Positive Airway pressure-RESPIRONICSTreated with CPAP |
| apnea/hypopnea index ( AHI≥30:severe OSAS untreated). | Sham comparator | Device: Sham Continuous Positive Airway pressure-RESPIRONICSTreated with sham CPAP (placebo) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Brain infarction confirmed by brain imaging
- NIHSS ≥ 4 or- isolated aphasia (item 9 ofNIHSS ≥ 1) or
- negligence (item 11 du NIHSS ≥ 2) or
- distal motor deficit (score ≥ 1)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway pressure-RESPIRONICSobstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap | Device | apnea/hypopnea index ( AHI≥30 : severe OSAS treated). |
| Sham Continuous Positive Airway pressure-RESPIRONICSinefficient Continuous Positivie Airway pressure | Device | apnea/hypopnea index ( AHI≥30:severe OSAS untreated). |
Primary outcome
functional independence scale
Time frame: 3 months
The variation of the functional independence scale is evaluated by the Barthel Index at three months after stroke in four groups of patients depending on their apnea/hypopnea.In the patients group severe OSAS treated with CPAP from day 15 after stroke compared to patients with severe OSAS treated with sham CPAPThe neurological dependency will be evaluated by the Barthel Index .This scale measures the consequences of the motor and cognitive disorders on the daily living with 10 items.
5 secondary outcomes
neurological impairment
Time frame: 3 months
the handicap
Time frame: 3 months
blood pressure
Time frame: 3 months
the quality of life
Time frame: 3 months
the survival
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 37338010Denis C, Jaussent I, Guiraud L, Mestejanot C, Arquizan C, Mourand I, Chenini S, Abril B, Wacongne A, Tamisier R, Baillieul S, Pepin JL, Barateau L, Dauvilliers Y. Functional recovery after ischemic stroke: Impact of different sleep health parameters. J Sleep Res. 2024 Feb;33(1):e13964. doi: 10.1111/jsr.13964. Epub 2023 Jun 20.
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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.
Yves DAUVILLIERS, MD-PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway pressure-RESPIRONICS in people with Obstructive Sleep Apnea Syndrome and Brain Infarction, run by University Hospital, Montpellier 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Jun 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves DAUVILLIERS, MD-PhD (y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional independence scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01561677, which also lists 1 linked publication.
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 11 Jun 2018.