Ischemic StrokeATACSNCT07044830
Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke
A study testing CPAP in people with Ischemic Stroke and Obstructive Sleep Apnea, run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
Trial summary
The study aims to evaluate whether early treatment of obstructive sleep apnea with continuous positive airway pressure in ischemic stroke patients has a favorable effect on functional recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, 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
- 425 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2024to 28 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supratentorial non-lacunar ischemic stroke, including anterior, middle, and posterior cerebral artery territories
- Aged 18 to 80 years
- Symptom onset or symptom recognition to admission < 12 hours
- NIHSS score ≥ 4 and ≤ 20 at enrollment
- Signed informed consent form obtained from the participant or their legal representative
Who cannot join
- Prior stroke
- Previous diagnosis of OSA with current CPAP use or previously failed CPAP
- Pre-stroke disability (mRS > 1)
- Coma or stupor
- Orotracheal intubation
- Clinical instability or severe pre-existing illness (e.g., heart failure, oxygen-dependent COPD, renal or hepatic failure)
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- Psychomotor agitation
- High likelihood of neurosurgical intervention within the first 48 hours
- Oxygen therapy >2 L/min
- Known severe neurological disease (e.g., dementia, Parkinson's disease, multiple sclerosis, or other neurodegenerative conditions)
- Chronic alcohol or drug use with high risk of withdrawal during hospitalization
- Pregnant or suspected pregnant women
- Inability to complete follow-up for any reason
- Any contraindication to CPAP use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, 14015-130
Millene Camilo, MD, PhD, +55-16-36021000, millene.camilo@fmrp.usp.br
Millene Camilo, MD, PhD
About this study
Official title: Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
The study aims to evaluate whether early treatment of obstructive sleep apnea with continuous positive airway pressure in ischemic stroke patients has a favorable effect on functional recovery.
Read the detailed description
Obstructive sleep apnea (OSA) is present in more than 70% of acute stroke patients, and has been related to poor short-and long-term outcomes. The treatment of choice for OSA is continuous positive airway pressure (CPAP).
The objective of this prospective, multicenter, randomized study is to evaluate the impact of CPAP treatment on clinical outcomes in post-stroke patients. Respiratory polygraphy will be performed in all eligible participants, and those with severe OSA will be randomized to receive either CPAP therapy or conservative management. CPAP use will initiated within the first 48-72 hours of hospital admission and continued through 2 years follow-up.
- Conditions
- Ischemic Stroke, Obstructive Sleep Apnea
- Being tested
- CPAP
- Keywords
- Stroke, Obstructive Sleep Apnea, Sleep
- Medical subject headings
- Ischemic Stroke, Sleep Apnea, Obstructive, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Automatically-adjusting continuous positive airway pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Severe OSA treated | Active comparator | AHI≥30: treated with CPAP Receives: Device: CPAP |
| Severe OSA untreated | No intervention | AHI≥30: without CPAP |
| No OSA | No intervention | AHI<5 |
| Mild OSA | No intervention | 5≥AHI<15 |
| Moderate OSA | No intervention | 15≤AHI<30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional disability
Measured by the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability and dependence on daily activities.
Measured: 3 months
Secondary outcomes (7)
Neurological impairment
Stroke severity will be measured by National Institutes of Health Stroke Scale, which ranges from 0 to 42, with higher scores reflecting greater neurological impairment. Neurological deterioration was defined as an increase of 4 or more points on the NIH Stroke Scale within 72 hours after stroke onset
Measured: Admission, 72 hours, day 5/discharge, 3 months, and 6 months
Functional independence
Measured by the modified Rankin Scale (dichotomized analysis with mRS ≤ 2) and the Barthel Index, which ranges from 0 (worst, fully dependent) to 100 (best, independent).
Measured: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years
Cognitive impairment
Evaluated through the Montreal Cognitive Assessment, which was developed as a brief screening instrument for mild cognitive impairment. It assesses different cognitive domains, scoring up to 30.
Measured: Day 5/discharge, 3 months, 1 year, and 2 years
Subjective quality of life
Measured by the EuroQol-5 Dimension (no problems = 1; some problems = 2; and extreme problems or unable to = 3).
Measured: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years
Depressive episode
Assessed using the MINI-International Neuropsychiatric Interview, which is a structured interview to assess symptoms related to depression. Questions are phrased to allow only "yes" or "no" answers.
Measured: Day 5/discharge, 3 months, 1 year, and 2 years
Excessive daytime sleepiness
Assessed using the Epworth Sleepiness Scale. The total score, calculated by adding up the values of each answer, ranges from 0 to 24. A score of 10 or higher indicates excessive daytime sleepiness.
Measured: Admission, 3 months, 6 months, 1 year, and 2 years
Mortality
Mortality resulting from any cause will be recorded throughout the study.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start28 Feb 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, ResMed Foundation
- Responsible party
- Principal investigator, Millene Rodrigues Camilo, Hospital das Clínicas de Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044830
- Sponsor's protocol ID
- 20802619.2.0000.5440
- Acronym
- ATACS
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07044830
- Acronym / sponsor ID
- ATACS / 20802619.2.0000.5440
- Conditions
- Ischemic Stroke, Obstructive Sleep Apnea
- Keywords
- Stroke, Obstructive Sleep Apnea, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Hospital das Clínicas de Ribeirão PretoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, ResMed Foundation
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 1 Jul 2025 (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.
The study aims to evaluate whether early treatment of obstructive sleep apnea with continuous positive airway pressure in ischemic stroke patients has a favorable effect on functional recovery.
Detailed description
Obstructive sleep apnea (OSA) is present in more than 70% of acute stroke patients, and has been related to poor short-and long-term outcomes. The treatment of choice for OSA is continuous positive airway pressure (CPAP).
The objective of this prospective, multicenter, randomized study is to evaluate the impact of CPAP treatment on clinical outcomes in post-stroke patients. Respiratory polygraphy will be performed in all eligible participants, and those with severe OSA will be randomized to receive either CPAP therapy or conservative management. CPAP use will initiated within the first 48-72 hours of hospital admission and continued through 2 years follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Severe OSA treated | Active comparator | Device: CPAPAHI≥30: treated with CPAP |
| Severe OSA untreated | No intervention | –AHI≥30: without CPAP |
| No OSA | No intervention | –AHI<5 |
| Mild OSA | No intervention | –5≥AHI<15 |
| Moderate OSA | No intervention | –15≤AHI<30 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Supratentorial non-lacunar ischemic stroke, including anterior, middle, and posterior cerebral artery territories
- Aged 18 to 80 years
- Symptom onset or symptom recognition to admission < 12 hours
- NIHSS score ≥ 4 and ≤ 20 at enrollment
- Signed informed consent form obtained from the participant or their legal representative
Key exclusion criteria (14 listed)
- Prior stroke
- Previous diagnosis of OSA with current CPAP use or previously failed CPAP
- Pre-stroke disability (mRS > 1)
- Coma or stupor
- Orotracheal intubation
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 |
|---|---|---|
| CPAPAutomatically-adjusting continuous positive airway pressure (CPAP) | Device | Severe OSA treated |
Primary outcome
Functional disability
Time frame: 3 months
Measured by the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability and dependence on daily activities.
7 secondary outcomes
Neurological impairment
Time frame: Admission, 72 hours, day 5/discharge, 3 months, and 6 months
Functional independence
Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years
Cognitive impairment
Time frame: Day 5/discharge, 3 months, 1 year, and 2 years
Subjective quality of life
Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years
Depressive episode
Time frame: Day 5/discharge, 3 months, 1 year, and 2 years
Excessive daytime sleepiness
Time frame: Admission, 3 months, 6 months, 1 year, and 2 years
Mortality
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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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.
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 Ischemic Stroke and Obstructive Sleep Apnea, run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
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 14 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Millene Camilo, MD, PhD (+55-16-36059075, millene.camilo@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.