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StrokeASCENTNCT04399200

Apnea, Stroke and Incident Cardiovascular Events

An observational study of Stroke and Sleep-disordered Breathing, run by University Hospital, Grenoble at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. Read more about this study

Who is it for?
Ages 18 to 85 years
Type of treatment
Medical device
How many people
1,620 participants
Where
1 siteFrance
Study dates
13 Jul 2020to 1 Jun 2035
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients in the acute phase (<72h) of a first stroke or initial/recurrent TIA, admitted in the stroke unit of the Grenoble Alpes University Hospital.

Who may be able to join

  • Male or female, aged 18 to 85 years
  • Admitted in the stroke unit no later than 72h after the onset of stroke symptoms:
  • First stroke confirmed by computed tomography scan or magnetic resonance imaging, whatever the localization
  • Initial or recurrent TIA, as defined by a brief and sudden neurological dysfunction for which an ischemic cause is presumed, with symptoms lasting less than 24 hours, and/or with no visible lesion on neuroimaging evaluation.
  • Score on the Modified Ranking scale (mRS) ≤1 before stroke
  • Signed informed consent by patient or his/her relative if not able
  • Patient eligible to carotid endarterectomy (for ancillary study only)

Who cannot join

  • Pregnant or breastfeeding women
  • Past history of stroke
  • Inability to follow rehabilitation procedure
  • Patients with ongoing treatment for SDB
  • Patients not affiliated to a French social and health insurance system or equivalent
  • Prisoners or patients who require protection by the law

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sébastien Baillieul, MD, MSc contact

+33 (0)4 76 76 75 40

sbaillieul@chu-grenoble.fr

Sara Saadi, MSc contact

+33 (0)4 76 76 86 90

ssaadi1@chu-grenoble.fr

France1 site, 1 recruiting

  • University Hospital Grenoble

    Grenoble, 38043

    Sébastien Baillieul, MD, MSc, +33 (0)4 76 75 40, sbaillieul@chu-grenoble.fr

    Sara Saadi, MSc, +33 (0)4 76 76 86 90, ssaadi1@chu-grenoble.fr

    Recruiting

Other trials in France

About this study

Official title: Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke

This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset.

The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease.

Read more

1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort.

Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) > 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.

Read the detailed description

This is a prospective cohort study that aims at comparing the proportion of incident cardiovascular events after a first stroke, first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing patients (SDB, defined as an apnea-hypopnea index > 15 events/hour) and non-SDB patients, one year after SDB diagnosis performed by polysomnography 3 months after the cerebrovascular event.

The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events (Major Adverse Cardiovascular Events, MACCEs), regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, non-fatal acute coronary event. Secondary outcomes include secondary cardiac and cerebrovascular events; stroke-related functional criteria; lesion-related criteria obtained from morphological MRI; scores on questionnaires assessing the quality of life, depression and sleep; functional, cognitive and sensorimotor evaluations; locomotion tests; and sleep-related criteria.

1620 patients, aged 18 to 85 years, in the acute phase (<72h) of a first stroke, first or recurrent TIA, and with a score on the modified Rankin Scale (mRS) ≤1 before stroke onset, will be included in the cohort. All patients included in the study will be followed for 5 years. The schedule of follow-up will be as follow :

  • Selection visit (Days 0 to 3): verification of eligibility criteria, patients' or relatives' information, informed consent signature.
  • Inclusion visit (Days 1 to 180): clinical history and treatments, clinical evaluation and anthropometrical parameters, stroke-related criteria (including score on the National Institute of Health Stroke Scale), functional, cognitive, and sensorimotor evaluation, walking and locomotion tests, questionnaires, stroke imagery by magnetic resonance imagery, blood sampling.
  • SDB diagnosis (Month 3): the same clinical, MRI and biological parameters will be collected and the same questionnaires will be fulfilled by the patients. In addition, they will undergo polysomnography to assess their SDB status. Patients will be assigned to the SDB group if the AHI > 15 events/hour; otherwise they will be assigned to the control group. Patients assigned to the SDB group will be proposed a treatment for their SDB according to standard care procedures.
  • Clinical follow-up: sleep and neurological; (initial 3 months and then annually after SDB diagnosis up to 5 years after SDB diagnosis): retrieval of new cardiac or cerebrovascular events (primary study outcome (MACCEs)), stroke-related parameters, questionnaires, functional, cognitive, and sensorimotor evaluations, locomotion tests, sleep follow-up (adherence to SDB treatment, tolerance, efficacy). Biological sampling will also be done at 1, 2 and 5 years after SDB diagnosis.

Ancillary study - CAtSS (Carotid, Atherosclerosis, Stroke and Sleep apnea) Conjointly to the previously described ASCENT protocol, an ancillary study will be proposed to the subgroup of patients eligible for carotid surgery (endarterectomy) following their cerebrovascular event.

The purpose of this ancillary study is to evaluate the impact of SDB and SDB treatment on the evolution of the carotid plaque after surgery. For the patients who accepted to participate to this ancillary study, the degree of carotid stenosis and the artery wall thickness (intima-media thickness, assessed by echo-Doppler) will be measured during the inclusion visit, at 3 months, 6 months, and at each annual visit. During surgery, a fragment of carotid plaque will be kept for morphologic and histologic analyses as well as miRNAs dosing, miARNs being recognized as indicators of carotid plaque instability. Plasmatic and urine samples will also be collected for miRNA analyses.

Being tested
Treatment according to standard care recommandation
Keywords
Stroke, Sleep-disordered Breathing, Cardio-Vascular Events, Atherosclerosis
Medical subject headings
Stroke, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Apnea, Central, Sleep Deprivation, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment according to standard care recommandationDevice

    SDB treatment according to standard care recommandation: Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Device, Positionnal Therapy, Adaptive Servo-Ventilation (ASV), Non-Invasive Ventilation (NIV)

Study groups in NCT04399200
Study groupRoleWhat they receive
Sleep-disordered breathing groupSleep-disordered breathing (SDB) patients (AHI>15/h, measured by polysomnography performed 3 months after stroke)
Receives: Device: Treatment according to standard care recommandation
Control groupControl patients with no SDB (AHI<15/h, measured by polysomnography performed 3 months after stroke)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)

    Composite endpoint composed of cardiac or cerebrovascular events regrouping: death from cardiac of cerebrovascular cause, non fatal stroke (either ischemic or hemorrhagic), and non-fatal acute coronary disease

    Measured: 1 year after SDB diagnosis

Secondary outcomes (33)

  1. Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)

    Composite endpoint composed of cardiac or cerebrovascular events regrouping: death from cardiac of cerebrovascular cause, non fatal stroke (either ischemic or hemorrhagic), and non-fatal acute coronary disease

    Measured: 5 years after SDB diagnosis

  2. Prevalence of secondary cardiac or cerebrovascular events

    Composite endpoint composed of cardiac or cerebrovascular events regrouping: transient ischemic attack (TIA), any acute coronary disease, hospitalization for any cardio-vascular cause and peripheral artery disease

    Measured: 5 years after SDB diagnosis

  3. Change in BMI from inclusion to 5 years

    Change in body mass index (BMI), defined as weight (Kg)/height (m)². This will be calculated at inclusion and at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  4. Change in waist, neck, and abdominal circumferences, from inclusion visit to 5 years

    Change in waist, neck and abdominal circumferences in cm. This will be measured at inclusion and at each visit.

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  5. Change in NIHSS score from inclusion to 5 years

    Stroke severity assessed by National Institute of Health Stroke Scale (NIHSS). This tool is composed of 15 items, each assessing specific abilities. (0: no stroke symptoms; 1 to 4: minor stroke; 5 to 15: moderate stroke; 16-20: moderate to severe stroke; >20 : severe stroke). The scale will be administered at each visit.

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  6. ABCD² score at inclusion

    Score evaluating the risk for stroke after a transient ischemic attack (TIA). The scale ranges from 0 (low level) to 7 (high level). 0 to 3: low risk; 4 to 5: moderate, 6 to 7: high risk

    Measured: at inclusion

  7. Clinical outcome: change in modified Ranking Sale (mRS) from inclusion to 5 years

    Scale assessing functional outcome after stroke, ranging from 0 (no symptoms at all) to 5 (severe disability), measured at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  8. Clinical outcome: change in Functional Independence Measure (FIM) from inclusion to 5 years

    Scale assessing functional outcome after stroke, ranging from 18 (totally dependent) to 126 (totally independent), measured at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  9. Clinical outcome: change in Stroke Impact Scale (SIS-16) from inclusion to 5 years

    This scale assess patient's health after stroke, through 16 items evaluating functional independence and mobility. This scale ranges from 16 (total independance) to 80 (total dependancy). The scale will be administer at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  10. Clinical outcome: change Patient Health Questionnaire (PHQ-9) from inclusion to 5 years

    Scale assessing patient's depression symptoms, administered at each visit. The scale ranges from 0 (no depression) to 27 (severe depression).

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  11. Clinical outcome: change Fugl-Meyer Assessment Scale from inclusion to 5 years

    Scale assessing sensori-motor upper extremity function in post-stroke patients, administered at each visit. The maximal possible score is 226, which corresponds to a complete sensori-motor recovery.

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  12. Change in walking and locomotion abilities: nFAC score, from inclusion to 5 years

    Evaluation of ambulation abilities, from 0 (cannot walk) to 8 (able to walk independantly)

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  13. Change in walking and locomotion abilities: 10m walking test, from inclusion to 5 years

    Evaluation of speed on the 10m walking test

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  14. Change in daytime sleepiness: score on the Epworth Sleepiness Scale, from inclusion to 5 years

    Daytime sleepiness score measured by Epworth Sleepiness Scale. The scale ranges from 0 (no sleepiness) to 24 (severe sleepiness)

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  15. Change in daytime sleepiness: score Berlin Questionnaire for Sleep Apnea (BQSA)

    Sleep apnea screening questionnaire that identifies the risk (from low to high) of sleep disordered breathing

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  16. Assessment of sleep and fatigue: score change on Chalder Fatigue Scale from inclusion to 5 years

    Questionnaire evaluating the severity of tiredness, on a scale ranging from 0 (no fatigue) to 33 (severe), administered at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  17. Assessment of sleep and fatigue: score change on Fatigue Severity Scale (FSS) from inclusion to 5 years

    Questionnaire evaluating the severity of tiredness, on a scale ranging from 9 (no fatigue) to 63 (severe), administered at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  18. Assessment of sleep and fatigue: score change on Pichot's Fatigue Scale from inclusion to 5 years

    Questionnaire evaluating the severity of tiredness, on a scale ranging from 0 (no fatigue) to 32 (severe), administered at each visit

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  19. Change in depression symptoms from inclusion to 5 years : Pichot's Depression Scale (QD2A)

    Questionnaire evaluating depression symptoms through right/false responses to 13 items, administered at each visit (score: 0 to 13)

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  20. Change in cognitive abilities from inclusion to 5 years: scores on the Montreal Cognitive Assessment Test

    Global assessment of cognitive functions, evaluating on 30 points and in 10 minutes short-term memory, verbal fluency, visuoconstructive abilities, executive functions, attention, working memory, language and spatiotemporal orientation. The test will be administered at each visit.

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  21. Change in cognitive abilities from inclusion to 5 years : scores on the Frontal Assessment Battery

    Short screening test evaluating executive function, on a scale from 0 (severe disability) to 18 (no disability)

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  22. Change in cognitive abilities from inclusion to 5 years : Language Screening Test (LAST)

    Rapid evaluation of language abilities (oral expression and comprehension) through 15 items (total score: 15).

    Measured: at inclusion, and at each visit up to 5 years after SDB diagnosis

  23. Prevalence of SDB assessed by polysomnography

    Prevalence of SDB, assessed by polysomnography, and defined as AHI (Apnea-Hypopnea Index >15/h)

    Measured: 3 months post-stroke

  24. Prevalence of respiratory disorders

    Respiratory assessments : spirometry, plethysmography, CO diffusion, blood gas measurement, measurement of ventilatory response to CO2

    Measured: 3 months post-stroke

  25. Change in adherence to SDB treatments, from 6 months to 5 years after SDB diagnosis

    Treatment adherence, assessed by CPAP monitoring (mean hours/night) if applicable

    Measured: from 6 months and at each visit up to 5 years after SDB diagnosis

  26. Stroke characteristics : lesion volume

    Stroke volume in mm3, determined on MRI/CT scan

    Measured: At inclusion

  27. Concentration of C-Reactive protein

    Concentration of C-Reactive protein by blood sampling

    Measured: 3 months

  28. Change in degree of carotid stenosis (ancillary study)

    NASCET (North American Symptomatic Carotid Endarterectomy) evaluation of carotid stenosis in percent by Echo-doppler

    Measured: from 3 months to 5 years after SDB diagnosis

  29. Change in intima-media thickness (ancillary study) from 3 months to 5 years

    Measurement of carotid intima-media thickness (in mm) by Echo-Doppler

    Measured: from 3 months to 5 years after SDB diagnosis

  30. Plasmatic and urinary miRNAs (ancillary study)

    miRNA expression and modulation in plasma and urine

    Measured: from 3 months to 5 years after SDB diagnosis

  31. miRNAs in carotid artery plaque (ancillary study)

    miARNs expression and modulation in carotid artery plaque

    Measured: At baseline (carotid surgery)

  32. Prevalence of post-operative complication (ancillary study)

    Prevalence of post-operative complication defined as post-operative hematomy, nerve palsy of nerves X and XII, per - post-operative ischemic or hemorragic strokes, myocardial infarction, death

    Measured: from 3 months to 5 years after SDB diagnosis

  33. Adipose tissue analysis (ancillary study)

    Morphological analysis of adipose tissue collected during endarteriectomy, expression of membrane and lipidic and glycemic markers, expression of inflammatory markers

    Measured: At baseline (carotid surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start13 Jul 2020
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2035 (estimated)

Resources

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
1,620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399200
Sponsor's protocol ID
2019-A03085-52
Other IDs
2019-A03085-52
Acronym
ASCENT
Status last verified
Feb 2025
First submitted
25 Mar 2020
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

    PubMed 30871944

  • Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. doi: 10.1016/j.jacc.2016.11.069.

    PubMed 28209226

  • Hermann DM, Bassetti CL. Role of sleep-disordered breathing and sleep-wake disturbances for stroke and stroke recovery. Neurology. 2016 Sep 27;87(13):1407-16. doi: 10.1212/WNL.0000000000003037. Epub 2016 Aug 3.

    PubMed 27488603

  • Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11.

    PubMed 30635478

  • Lisabeth LD, Sanchez BN, Lim D, Chervin RD, Case E, Morgenstern LB, Tower S, Brown DL. Sleep-disordered breathing and poststroke outcomes. Ann Neurol. 2019 Aug;86(2):241-250. doi: 10.1002/ana.25515. Epub 2019 Jun 19.

    PubMed 31155749

  • Brill AK, Horvath T, Seiler A, Camilo M, Haynes AG, Ott SR, Egger M, Bassetti CL. CPAP as treatment of sleep apnea after stroke: A meta-analysis of randomized trials. Neurology. 2018 Apr 3;90(14):e1222-e1230. doi: 10.1212/WNL.0000000000005262. Epub 2018 Mar 9.

    PubMed 29523641

  • Amarenco P, Lavallee PC, Labreuche J, Albers GW, Bornstein NM, Canhao P, Caplan LR, Donnan GA, Ferro JM, Hennerici MG, Molina C, Rothwell PM, Sissani L, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wong LK; TIAregistry.org Investigators. One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke. N Engl J Med. 2016 Apr 21;374(16):1533-42. doi: 10.1056/NEJMoa1412981.

    PubMed 27096581

  • Amarenco P, Lavallee PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Kral M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.

    PubMed 29766771

  • Wardlaw JM, Brazzelli M, Chappell FM, Miranda H, Shuler K, Sandercock PA, Dennis MS. ABCD2 score and secondary stroke prevention: meta-analysis and effect per 1,000 patients triaged. Neurology. 2015 Jul 28;85(4):373-80. doi: 10.1212/WNL.0000000000001780. Epub 2015 Jul 1.

    PubMed 26136519

  • Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.

    PubMed 28626052

  • Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjogren M, Wallin A, Ader H, Leys D, Pantoni L, Pasquier F, Erkinjuntti T, Scheltens P; European Task Force on Age-Related White Matter Changes. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001 Jun;32(6):1318-22. doi: 10.1161/01.str.32.6.1318.

    PubMed 11387493

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.

    PubMed 28122885

  • Cramer SC, Wolf SL, Adams HP Jr, Chen D, Dromerick AW, Dunning K, Ellerbe C, Grande A, Janis S, Lansberg MG, Lazar RM, Palesch YY, Richards L, Roth E, Savitz SI, Wechsler LR, Wintermark M, Broderick JP. Stroke Recovery and Rehabilitation Research: Issues, Opportunities, and the National Institutes of Health StrokeNet. Stroke. 2017 Mar;48(3):813-819. doi: 10.1161/STROKEAHA.116.015501. Epub 2017 Feb 7. No abstract available.

    PubMed 28174324

  • Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.

    PubMed 24788967

  • Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

    PubMed 31300334

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Sleep-disordered Breathing, run by University Hospital, Grenoble 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sébastien Baillieul, MD, MSc (+33 (0)4 76 76 75 40, sbaillieul@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs) (time frame: 1 year after SDB diagnosis). 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 NCT04399200, which also lists 50 linked publications.

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 Feb 2025.

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Apnea, Stroke and Incident Cardiovascular Events | AzTrials