Ischemic StrokePSG-AVCNCT04816136
Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
An observational study of Ischemic Stroke and Cerebral Infarct, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke, Cerebral Infarct, Sleep Apnea
- What is being tested?
- Sleep recording (already done)
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2002to 1 Mar 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected with computer codes of disease and examination corresponding to the criteria : sleep recording and ischemic stroke
Who may be able to join
- men and women, more than 18 years old
- medical history of ischemic stroke
- who had a sleep recording following the stroke
Who cannot join
- others types of strokes (bleeding, transient ischemic attack, cerebal veinous thrombosis)
- patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities.
Furthermore, there is no clear guideline showing the usefulness of a systematic sleep investigation following an ischemic stroke.
The aim of the study is to identify retrospectively correlation between polysomnographic abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture…) and functional recovery after an ischemic stroke. The study also assesses the impact of sleep abnormalities on survival, and the risk of new cardiovascular event.
Read the detailed description
This study is a retrospective observational study, from a cohort of patients who had a sleep recording (polysomnography or ventilatory polygraphy performed in Montpellier University Hospital) following an ischemic stroke.
- Being tested
- Sleep recording (already done)
- Keywords
- Functional recovery, Ischemic stroke / cerebral infarct, Sleep, Polysomnography
- Medical subject headings
- Ischemic Stroke, Cerebral Infarction, Sleep Apnea Syndromes, Nocturnal Myoclonus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep recording (already done)Other
Sleep recording (already done)
| Study group | Role | What they receive |
|---|---|---|
| patients with a sleep recording performed | patients with a sleep recording performed in the sleep unit in Montpellier University Hospital, who had an ischemic stroke before the recording. Receives: Other: Sleep recording (already done) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between polysomnographic abnormalities and functional recovery
polysomnographic abnormalities : sleep apnea, periodic limb movements, distribution of sleep stage / functional recovery : modified rankin score and National Institutes of Health Stroke Scale at 6 months
Measured: functional recovery at 6 months
Secondary outcomes (1)
Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life.
polysomnographic abnormalities : sleep apnea, periodic limb movements, distribution of sleep stage / survival or onset of cardio vascular events, quality of life (SF 36), modified rankin score and National Institutes of Health Stroke Scale at one year.
Measured: survival or onset of new cardio vascular events at one year, quality of life evaluated by self questionnaire at one year and functionnal recovery (modified rankin score and National Institutes of Health Stroke Scale) at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jan 2002
- Primary completion1 Apr 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves DAUVILLIERS, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816136
- Sponsor's protocol ID
- RECHMPL20_0120
- Acronym
- PSG-AVC
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04816136
- Acronym / sponsor ID
- PSG-AVC / RECHMPL20_0120
- Keywords
- Functional recovery, Ischemic stroke / cerebral infarct, Sleep, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- 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.
Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities.
Furthermore, there is no clear guideline showing the usefulness of a systematic sleep investigation following an ischemic stroke.
The aim of the study is to identify retrospectively correlation between polysomnographic abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture…) and functional recovery after an ischemic stroke. The study also assesses the impact of sleep abnormalities on survival, and the risk of new cardiovascular event.
Detailed description
This study is a retrospective observational study, from a cohort of patients who had a sleep recording (polysomnography or ventilatory polygraphy performed in Montpellier University Hospital) following an ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a sleep recording performed | – | Other: Sleep recording (already done)patients with a sleep recording performed in the sleep unit in Montpellier University Hospital, who had an ischemic stroke before the recording. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected with computer codes of disease and examination corresponding to the criteria : sleep recording and ischemic stroke
Key inclusion criteria (3 listed)
- men and women, more than 18 years old
- medical history of ischemic stroke
- who had a sleep recording following the stroke
Key exclusion criteria (2 listed)
- others types of strokes (bleeding, transient ischemic attack, cerebal veinous thrombosis)
- patients less than 18 years old
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 |
|---|---|---|
| Sleep recording (already done)Sleep recording (already done) | Other | patients with a sleep recording performed |
Primary outcome
Correlation between polysomnographic abnormalities and functional recovery
Time frame: functional recovery at 6 months
polysomnographic abnormalities : sleep apnea, periodic limb movements, distribution of sleep stage / functional recovery : modified rankin score and National Institutes of Health Stroke Scale at 6 months
1 secondary outcome
Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life.
Time frame: survival or onset of new cardio vascular events at one year, quality of life evaluated by self questionnaire at one year and functionnal recovery (modified rankin score and National Institutes of Health Stroke Scale) at one year
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 25 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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 study director
University Hospital, Montpellier
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 Ischemic Stroke and Cerebral Infarct, 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 3 inclusion and 2 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 25 Mar 2021. 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?
Correlation between polysomnographic abnormalities and functional recovery (time frame: functional recovery at 6 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 25 Mar 2021.