An interventional study of CPAP in Ischemic Stroke and Obstructive Sleep Apnea, sponsored by Hospital das Clínicas de Ribeirão Preto. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Hospital das Clínicas de Ribeirão Preto · Not applicable, Interventional, and Treatment
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.
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 425 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Hospital das Clínicas de Ribeirão Preto is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AHI≥30: treated with CPAP
Device: CPAP
AHI≥30: without CPAP
AHI\<5
5≥AHI\<15
15≤AHI\<30
Automatically-adjusting continuous positive airway pressure (CPAP)
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.
Time frame: 3 months
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
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Admission, 3 months, 6 months, 1 year, and 2 years
Mortality
Mortality resulting from any cause will be recorded throughout the study.
Time frame: 2 years
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Hospital das Clínicas de Ribeirão Preto