CPAP on Acute Stroke and OSA

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Far Eastern Memorial Hospital
Updated on 19 February 2024
ct scan
stroke
computed tomography
heart failure
sleep apnea
acute coronary syndrome
somnolence
apnea
continuous positive airway pressure
acute stroke
central sleep apnea
recurrent strokes
recurrent stroke
heart failure, acute
heart failure acute

Summary

Stroke affects 16.9 million individuals each year and is the second leading cause of death worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of hospitalization for stroke remain high. These data emphasize the importance of identifying all treatable conditions that could aggravate stroke. One such condition is obstructive sleep apnea (OSA).

Sleep-related breathing disorders, including obstructive and central sleep apnea, often coexist with stroke. Compared to the general population, in whom OSA is the most common form of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes, accelerated neurological recovery.Apart from the benefits in better neurological outcomes, secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control studies to prove CPAP treatment would reduce the recurrence of cardiovascular or cerebrovascular events.

Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA. Notably, all of these studies above are observational or retrospective in nature. To date, there are no prospective longitudinal randomized controlled trials reporting the effect of CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized , controlled trial involving patients with stroke to test the primary hypothesis that treatment of OSA with CPAP would reduce the size of LA.

Details
Condition Cerebrovascular accident, Obstructive sleep apnea
Age 20years - 80years
Treatment CPAP
Clinical Study IdentifierNCT04458779
SponsorFar Eastern Memorial Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Time from onset of stroke symptoms to hospital arrival <2 weeks
Stroke is documented with brain magnetic imaging or computed tomography
Competency to provide informed consent
Moderate to severe obstructive sleep apnea being established with the use of a home sleep-study screening device (ApneaLink)
Epworth sleepiness scale10

Exclusion Criteria

Having received CPAP for obstructive sleep apnea prior to admission
History of pneumothorax or brain surgery
Coexisting heart failure or renal failure or persistent atrial fibrillation
Unable to wear a nasal or nasal-oral mask
Concomitant uncontrolled infection
Swallowing difficulty or episodes of choking due to stroke
Coexisting central nervous diseases such as dementia
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