Ischemic Stroke, Obstructive Sleep Apnea
Conditions
Keywords
Stroke, Obstructive Sleep Apnea, Sleep
Brief 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.
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.
Interventions
DEVICECPAP
Automatically-adjusting continuous positive airway pressure (CPAP)
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
ResMed Foundation
Hospital das Clínicas de Ribeirão Preto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional disability | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional independence | 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). |
| Cognitive impairment | 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. |
| Subjective quality of life | 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). |
| Neurological impairment | 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 |
| Excessive daytime sleepiness | 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. |
| Mortality | 2 years | Mortality resulting from any cause will be recorded throughout the study. |
| Depressive episode | 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. |
Countries
Brazil
Contacts
Primary ContactMillene Camilo, MD, PhD
Outcome results
None listed