CPAP on Acute Stroke and OSA

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04458779

Collaborator

(none)

100

Enrollment

Location

Arms

41.8

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Obstructive Sleep Apnea	Device: CPAP	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea

Actual Study Start Date :

Jul 9, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP group Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.	Device: CPAP CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
No Intervention: Usual-care group Subjects will receive optimal standard therapy for acute stroke.

Arm

Intervention/Treatment

Experimental: CPAP group

Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.

Device: CPAP

CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.

No Intervention: Usual-care group

Subjects will receive optimal standard therapy for acute stroke.

Outcome Measures

Primary Outcome Measures

Change in left atrium volume index (LAVI) [12 months]
Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.

Secondary Outcome Measures

Serial change of NT-proBNP [12 months]
Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
Neurological and functional assessments-1 [12 months]
Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.
Neurological and functional assessments-2 [12 months]
Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
Neurological and functional assessments-3 [12 months]
Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
Change in Quality of life assessments [12 months]
Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.

Other Outcome Measures

Numbers of cardiovascular or cerebrovascular events [12 months]
Numbers of cardiovascular or cerebrovascular events post randomization
Time to cardiovascular or cerebrovascular events [12 months]
Time to cardiovascular or cerebrovascular events post randomization
Numbers of all-cause hospitalizations [12 months]
Numbers of hospitalizations for any reason post randomization
Number of deaths [12 months]
Numbers of deaths from all causes post randomization
Time to deaths [12 months]
Time to deaths from all causes post randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 scale≦10.