|- candidate number||12303|
|- NTR Number||NTR3412|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2012|
|- Secondary IDs||NL37330 CCMO|
|- Public Title||Treatment of obstructive sleep apnea and rehabilitation outcome in stroke.|
|- Scientific Title||Treatment of obstructive sleep apnea and rehabilitation outcome in stroke.|
|- hypothesis||In this study the relationship of OSAS with cognitive and functional status, and the effect of treatment with CPAP on outcomes of rehabilitation in stroke patients will be investigated.|
The main research questions are:
1. Is there a relationship between (the severity of) OSAS and cognitive and functional status?
2. Does CPAP treatment improve cognitive and functional outcome of rehabilitation?
Firstly, we expect to confirm that OSAS has an additional negative effect in stroke patients on cognitive and functional status. Secondly, we expect that CPAP treatment will improve outcomes of rehabilitation in stroke patients.
|- Healt Condition(s) or Problem(s) studied||Sleep apnea, Obstructive sleep apnea syndrome, Stroke, Rehabilitation, CPAP|
|- Inclusion criteria||1. Stroke confirmed by neurological assessment and CT-scan or MRI-scan;|
2. Baseline measurement (T=0) between 1 to 16 weeks after stroke;
3. Able to cooperate with SAS screening and neuropsychological assessment;
4. Informed consent for study participation;
5. 18-85 years of age;
6. Obstructive or mixed SAS (for intervention part of the study).
|- Exclusion criteria||1. Severe unstable medical conditions;|
2. Severe cardiac problems (like angina pectoris or pacemaker/ventricular impairments);
3. Severe pulmonary disease (severe dyspnea of effort or severe pulmonary emphysema);
4. Severe aphasia or confusion, which could strongly influence the performance on the
5. Severe psychiatric or somatic comorbidity, which could strongly influence the performance on
the neuropsychological assessment;
6. Central SAS only;
7. Obesity hypoventilation syndrome;
8. Severe OSAS (AHI > 60 in combination with desaturations below 70%), which could
endanger patientís health if treatment is not immediately started.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-okt-2011|
|- planned closingdate||1-jun-2015|
|- Target number of participants||70|
|- Interventions||CPAP treatment. Patients will be randomized between two groups:|
1. Patients receive CPAP directly;
2. Patients will receive CPAP after 4 weeks.
|- Primary outcome||1. Neuropsychological assessment;|
2. functional assessment.
|- Secondary outcome||1. Sleep quality (actigraph);|
2. Fatige (CIS-20r);
3. Mood (HADS).
|- Timepoints||4 weeks and 3 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Justine Aaronson|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. B. Schmand|
|- Sponsor/Initiator ||University of Amsterdam (UVA), Heliomare R&D|
(Source(s) of Monetary or Material Support)
|Heliomare Research and Development|
|- Brief summary||Several studies have shown a relationship between obstructive sleep apnea syndrome
(OSAS) and cardiovascular diseases, such as hypertension, heart disease and stroke. OSAS has also been associated with an increase of fatigue and depression, and a decrease of cognitive functioning.|
Stroke patients with OSAS have found to be more functionally impaired than stroke patients without OSAS. Moreover, OSAS seems to have an additional negative effect on existing cognitive deficits
due to the stroke. Continuous positive airway pressure (CPAP) is the most frequently used method of
treatment for OSAS. Although research on CPAP treatment in stroke patients is still scarce, treatment is found to improve rehabilitation outcome of stroke patients.
In this study the relationship of OSAS with cognitive and functional status, and the effect of treatment with CPAP on outcomes of rehabilitation in stroke patients will be investigated.
|- Main changes (audit trail)|
|- RECORD||26-apr-2012 - 10-nov-2012|