Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital das Clínicas de Ribeirão Preto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior stroke
Previous diagnosis of OSA with current CPAP use or previously failed CPAP
Pre-stroke disability (mRS > 1)
Coma or stupor
Trial design
Design model
Parallel
Treatments tested in this trial
CPAP
DeviceAutomatically-adjusting continuous positive airway pressure (CPAP)
Treatment groups
425 Participants
are divided into 5 treatment groupsGroup A: Severe OSA treatedActive comparator 1 intervention
Group B: Severe OSA untreatedNo intervention 0 interventions
Group C: No OSANo intervention 0 interventions
Group D: Mild OSANo intervention 0 interventions
Group E: Moderate OSANo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital das Clínicas de Ribeirão Preto
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
ResMed Foundation
Collaborator
Source ClinicalTrials.gov