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To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.
The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.
Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.
Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASV therapy + best medical treatment for stroke, including rehabilitation | Experimental | Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation. |
|
| Best medical treatment for stroke, including rehabilitation | Active Comparator | Best medical treatment for stroke, including rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Servoventilation (ASV) therapy | Device | Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke. | 1 month after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke. | 4 and 6 months after stroke | |
| Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sílvia Correia, MD | Contact | 00351969043466 | silviapaiscorreia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sílvia Correia, MD | Trofa Saúde Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde de Matosinhos | Recruiting | Matosinhos Municipality | Portugal |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D012891 | Sleep Apnea Syndromes |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Best medical treatment | Other | Best medical treatment for stroke, including rehabilitation |
|
| 1, 4 and 6 months after stroke |
| Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™ | Within 7 days after admission |
| Adherence in the Servoventilation group | % nights of device use; average hours per night of device use | After 1, 4 and 6 months |
| Efficacy in the Servoventilation group | Apnea-Hypopnea Index | After 1, 4 and 6 months |
| Adverse events monitoring | All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived. | Through study completion, an average of 2 years |
| Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients | 1, 4 and 6 months after stroke |
| Cardiovascular events evaluation 12 months after stroke in all participants. | 12 months after stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |