Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke

Hospital das Clínicas de Ribeirão Preto425 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

425

Conditions

Ischemic Stroke Obstructive Sleep Apnea

Interventions

CPAPDEVICE

Automatically-adjusting continuous positive airway pressure (CPAP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Ribeirão Preto, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Central Contacts

Millene Camilo, MD, PhD

CONTACT

+55-16-36059075 millene.camilo@fmrp.usp.br

Data from ClinicalTrials.gov

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