Continuous Positive Airway Pressure on Acute Stroke and Obstructive Sleep Apnea

NCT04458779 | Completed DMC

• 1 other identifier: 109018-E
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; stroke; continuous positive airway pressure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Neurological and functional assessments-1

  12 months

• Neurological and functional assessments-2

  12 months

• Neurological and functional assessments-3

  12 months

• Change in Quality of life assessments

  12 months

Other Outcomes (5)

• Numbers of cardiovascular or cerebrovascular events

  12 months

• Time to cardiovascular or cerebrovascular events

  12 months

• Numbers of all-cause hospitalizations

  12 months

Study Arms (2)

CPAP group

EXPERIMENTAL

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

Device: CPAP

Usual-care group

NO INTERVENTION

Subjects will receive optimal standard therapy for acute stroke.

Interventions

CPAP DEVICE

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

CPAP group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Stroke; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Chou-Han Lin, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principical investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: July 9, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

TW (1)