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
Millene Camilo, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07044830
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14015-130, Brazil
Location status: Recruiting
Millene Camilo, MD, PhD
CONTACT
Millene Camilo, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Automatically-adjusting continuous positive airway pressure (CPAP)
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.
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
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).
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.
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).
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.
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.
Time frame: 2 years
Mortality resulting from any cause will be recorded throughout the study.
Contact information is provided by the study sponsor or research team.
Hospital das Clínicas de Ribeirão Preto
Other
Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
Acronym: ATACS
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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