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NCT Number: NCT07044830

Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location status: Recruiting

Location contact

Millene Camilo, MD, PhD

CONTACT

[email protected]

+55-16-36021000

Millene Camilo, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

CPAP

Device

Automatically-adjusting continuous positive airway pressure (CPAP)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neurological impairment

    Time frame: Admission, 72 hours, day 5/discharge, 3 months, and 6 months

    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

  2. Functional independence

    Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years

    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).

  3. Cognitive impairment

    Time frame: Day 5/discharge, 3 months, 1 year, and 2 years

    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.

  4. Subjective quality of life

    Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years

    Measured by the EuroQol-5 Dimension (no problems = 1; some problems = 2; and extreme problems or unable to = 3).

  5. Depressive episode

    Time frame: Day 5/discharge, 3 months, 1 year, and 2 years

    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.

  6. Excessive daytime sleepiness

    Time frame: Admission, 3 months, 6 months, 1 year, and 2 years

    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.

  7. Mortality

    Time frame: 2 years

    Mortality resulting from any cause will be recorded throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Millene Camilo, MD, PhD

CONTACT

[email protected]

+55-16-36059075

Sponsors and collaborators

Lead sponsor

Hospital das Clínicas de Ribeirão Preto

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • ResMed Foundation

Registry information

Official study title

Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial

Acronym: ATACS

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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