CPAP on Acute Stroke and OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458779
• Other study ID #: 109018-E
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2020
• Source: Far Eastern Memorial Hospital
• Contact: Pei-Chen Lai, BD
• Phone: 8966-7000
• Email: sleepra01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Time from onset of stroke symptoms to hospital arrival <2 weeks .

2. Stroke is documented with brain magnetic imaging or computed tomography

3. Competency to provide informed consent.

4. Moderate to severe obstructive sleep apnea being established with the use of a home sleep-study screening device (ApneaLink).

5. Epworth sleepiness scale?10.

Exclusion Criteria:

1. Having received CPAP for obstructive sleep apnea prior to admission.

2. History of pneumothorax or brain surgery.

3. Coexisting heart failure or renal failure or persistent atrial fibrillation.

4. Unable to wear a nasal or nasal-oral mask.

5. Concomitant uncontrolled infection.

6. Swallowing difficulty or episodes of choking due to stroke

7. Coexisting central nervous diseases such as dementia

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Stroke, Acute

Intervention

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numbers of cardiovascular or cerebrovascular events	Numbers of cardiovascular or cerebrovascular events post randomization	12 months
Other	Time to cardiovascular or cerebrovascular events	Time to cardiovascular or cerebrovascular events post randomization	12 months
Other	Numbers of all-cause hospitalizations	Numbers of hospitalizations for any reason post randomization	12 months
Other	Number of deaths	Numbers of deaths from all causes post randomization	12 months
Other	Time to deaths	Time to deaths from all causes post randomization	12 months
Primary	Change in left atrium volume index (LAVI)	Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.	12 months
Secondary	Serial change of NT-proBNP	Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.	12 months
Secondary	Neurological and functional assessments-1	Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.	12 months
Secondary	Neurological and functional assessments-2	Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.	12 months
Secondary	Neurological and functional assessments-3	Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.	12 months
Secondary	Change in Quality of life assessments	Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.	12 months