Stroke, AcuteNCT04458779
Continuous Positive Airway Pressure on Acute Stroke and Obstructive Sleep Apnea
A study testing CPAP in people with Stroke, Acute and Obstructive Sleep Apnea, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Acute, Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea
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
- Being tested
- CPAP
- Keywords
- obstructive sleep apnea, stroke, continuous positive airway pressure
- Medical subject headings
- Stroke, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Experimental | Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke. Receives: Device: CPAP |
| Usual-care group | No intervention | Subjects will receive optimal standard therapy for acute stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
Neurological and functional assessments-2
Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
Measured: 12 months
Neurological and functional assessments-3
Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start9 Jul 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chou-Han Lin, Far Eastern Memorial Hospital
- Investigators
- Chou-Han Lin, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458779
- Sponsor's protocol ID
- 109018-E
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CH, Huang SH, Chu YC, Huang YS, Fong VH, Tang CW, Wu YW. Effect of Continuous Positive Airway Pressure on Left Atrial Volume Index in Patients With Stroke and Obstructive Sleep Apnea: A Randomized Trial. J Am Heart Assoc. 2026 Sep 24:e050964. doi: 10.1161/JAHA.126.050964. Online ahead of print.
PubMed 42786612
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04458779
- Acronym / sponsor ID
- 109018-E
- Conditions
- Stroke, Acute, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, stroke, continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Experimental | Device: CPAPSubjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke. |
| Usual-care group | No intervention | –Subjects will receive optimal standard therapy for acute stroke. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke. | Device | CPAP group |
Primary outcome
Change in left atrium volume index (LAVI)
Time frame: 12 months
Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.
Serial change of NT-proBNP
Time frame: 12 months
Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
4 secondary outcomes
Neurological and functional assessments-1
Time frame: 12 months
Neurological and functional assessments-2
Time frame: 12 months
Neurological and functional assessments-3
Time frame: 12 months
Change in Quality of life assessments
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 42786612Lin CH, Huang SH, Chu YC, Huang YS, Fong VH, Tang CW, Wu YW. Effect of Continuous Positive Airway Pressure on Left Atrial Volume Index in Patients With Stroke and Obstructive Sleep Apnea: A Randomized Trial. J Am Heart Assoc. 2026 Sep 24:e050964. doi: 10.1161/JAHA.126.050964. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chou-Han Lin, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Stroke, Acute and Obstructive Sleep Apnea, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left atrium volume index (LAVI) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.