Actively Recruiting

Age: 18Years - 85Years
All Genders
ID04399200

Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events After a First Stroke

Led by University Hospital, Grenoble · Updated on 2025-02-11

1620

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the occurrence of major heart and brain-related events in patients after their first stroke, first transient ischemic attack (TIA), or recurrent TIA. This research compares patients with sleep-disordered breathing (SDB) to those without SDB one year after diagnosing SDB three months post-stroke. The primary focus is on a combined measure of serious cardiac or brain events including death, non-fatal stroke, and acute coronary disease. The study includes 1620 patients aged 18 to 85 who are in the acute phase of a stroke or TIA and have low disability before the event. Patients will be grouped based on polysomnography results performed three months after their stroke or TIA to diagnose SDB, defined by an apnea-hypopnea index higher than 15 events per hour. Those with SDB will receive treatment according to standard care, such as Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, positional therapy, adaptive servo-ventilation, or non-invasive ventilation. The study follows patients over five years, with assessments at enrollment, three months, and annually after SDB diagnosis. Participants undergo detailed clinical, imaging, cognitive, sensorimotor, and biological evaluations at various points, including stroke imaging, blood sampling, and questionnaires on quality of life, depression, and sleep. Regular follow-up assesses new cardiac or cerebrovascular events, stroke-related outcomes, treatment adherence, and cognitive and functional abilities. An ancillary study focuses on patients eligible for carotid surgery, evaluating plaque changes and molecular markers. The primary outcome measure is collected one year after SDB diagnosis, with long-term monitoring continuing up to five years.

CONDITIONS

Brief Title

Apnea, Stroke and Incident Cardiovascular Events

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18 to 85 years
  • Admitted to stroke unit within 72 hours after stroke symptoms
  • First stroke confirmed by CT scan or MRI
  • Initial or recurrent transient ischemic attack (TIA) with symptoms less than 24 hours
  • Modified Rankin Scale score 641 before stroke
  • Signed informed consent by patient or relative if patient unable
  • Eligible for carotid endarterectomy (ancillary study only)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Past history of stroke
  • Unable to follow rehabilitation procedures
  • Currently receiving treatment for sleep-disordered breathing
  • Participating in another study with exclusion period
  • Not affiliated with French social and health insurance or equivalent
  • Prisoners or legally protected patients

AI-Screening

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Your Study Journey

Screening

Duration - Up to 3 days

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) within 72 hours after stroke symptoms

Inclusion and Baseline Assessments

Duration - From Day 1 to 6 months after stroke

Participants undergo clinical history review, clinical evaluation, anthropometrical measurements, stroke-related assessments, functional, cognitive, and sensorimotor evaluations, walking and locomotion tests, questionnaires, stroke MRI imaging, and blood sampling.

1 to multiple visits during inclusion period

Sleep Apnea Diagnosis

Duration - At 3 months after stroke

Participants undergo polysomnography to diagnose sleep-disordered breathing and repeat clinical, MRI, and biological assessments, as well as questionnaires.

1 visit (in-person) for polysomnography and assessments

Treatment (for SDB group)

Duration - From diagnosis and ongoing as per clinical indication

Participants diagnosed with sleep-disordered breathing receive treatment according to standard care recommendations, including CPAP, mandibular advancement device, positional therapy, adaptive servo-ventilation, or non-invasive ventilation.

Treatment adherence and tolerance monitored during follow-up visits

Clinical and Sleep Follow-up

Duration - Initial 3 months and then annually up to 5 years after sleep apnea diagnosis

Participants are followed for neurological and sleep outcomes including assessment of new cardiac or cerebrovascular events, stroke-related parameters, questionnaires, functional, cognitive and sensorimotor evaluations, locomotion tests, and sleep treatment adherence and efficacy monitoring. Biological sampling is also performed.

Multiple visits: initial 3 months of clinical follow-up plus annual visits up to 5 years

Ancillary Study for Carotid Surgery Patients

Duration - From baseline (carotid surgery) through 5 years after sleep apnea diagnosis

Participants eligible for carotid surgery undergo additional assessments including carotid stenosis and artery wall thickness measurements, plaque analysis during surgery, and miRNA analyses in plasma, urine, and carotid plaque.

Visits at inclusion, 3 months, 6 months, and annually up to 5 years

Trial Site Locations

Total: 1 location

1

University Hospital Grenoble

Grenoble, France, 38043

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Research Team

S

Sébastien Baillieul, MD, MSc

S

Sara Saadi, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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