Sleep DisorderSOMN'AICNCT03274505
Sleep Disorders in Transient Ischemic Attack and Stroke: SOMN'AIC Study
An observational study of Sleep Disorder and Stroke, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder, Stroke
- What is being tested?
- Questionnaires
- How many people
- 153 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Nov 2017to 3 Nov 2022
- 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: Stroke and transient ischemic attack patients
Who may be able to join
- Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3 month' rehabilitation examination
- TIA group: diagnosis of a TIA by a stroke specialist at the "SOS TIA" examination
- > 18 years
Who cannot join
- Refusal to participate
- Severe cognitive impairment leading to inability to fulfil questionnaires
- For the TIA group: presence of an ischemic lesion on CT scan or MRI
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Neurologie Vasculaire Groupement Hospitalier Est
Bron, 69477
Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
Lyon, 69004
Service de MPR- Hôpital Henry Gabrielle - Groupement Sud
Saint-Genis-Laval, 69230
About this study
Official title: Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke
Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.
- Conditions
- Sleep Disorder, Stroke
- Being tested
- Questionnaires
- Medical subject headings
- Sleep Wake Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
- Clinical evaluation
- Routine neuropsychological evaluation (for stroke patients)
- Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) > 10)
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination Receives: Other: Questionnaires | |
| TIA patients | Patients seen by a stroke specialist at the "SOS TIA" examination Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder
Presence of at least one of the following sleep disorders assessed by clinical evaluation, questionnaires +/- polysomnography: insomnia, excessive daytime sleepiness (EDS), restless legs syndrome (RLS) and sleep apnoea syndrome (SAS)
Measured: Maximum 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start14 Nov 2017
- Primary completion11 Jun 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cross-sectional
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure PETER-DEREX, MD, PhD, Principal investigator, Centre de Médecine du Sommeil et des Maladies respiratoires, CH de la Croix Rousse - HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274505
- Sponsor's protocol ID
- 69HCL17_0418
- Acronym
- SOMN'AIC
- Status last verified
- Jul 2024
- First submitted
- 5 Sep 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke
- ClinicalTrials.gov ID
- NCT03274505
- Acronym / sponsor ID
- SOMN'AIC / 69HCL17_0418
- Conditions
- Sleep Disorder, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 7 Sep 2017 (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.
Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: QuestionnairesPatients seen by a rehabilitation physician at a routine 3 months' post-stroke examination |
| TIA patients | – | Other: QuestionnairesPatients seen by a stroke specialist at the "SOS TIA" examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke and transient ischemic attack patients
Key inclusion criteria (3 listed)
- Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3 month' rehabilitation examination
- TIA group: diagnosis of a TIA by a stroke specialist at the "SOS TIA" examination
- > 18 years
Key exclusion criteria (3 listed)
- Refusal to participate
- Severe cognitive impairment leading to inability to fulfil questionnaires
- For the TIA group: presence of an ischemic lesion on CT scan or MRI
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 |
|---|---|---|
| Questionnaires* Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire) * Clinical evaluation * Routine neuropsychological evaluation (for stroke patients) * Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) > 10) | Other | Stroke patients, TIA patients |
Primary outcome
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder
Time frame: Maximum 9 months
Presence of at least one of the following sleep disorders assessed by clinical evaluation, questionnaires +/- polysomnography: insomnia, excessive daytime sleepiness (EDS), restless legs syndrome (RLS) and sleep apnoea syndrome (SAS)
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 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Laure PETER-DEREX, MD, PhD principal investigator
Centre de Médecine du Sommeil et des Maladies respiratoires, CH de la Croix Rousse - HCL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Stroke, run by Hospices Civils de Lyon at 3 sites 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 3 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder (time frame: Maximum 9 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 23 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.