No registrations found.
ID
Source
Brief title
Health condition
sleep apnea
OSAS
stroke
CPAP
rehabilitation
Sponsors and support
Heliomare R&D
Relweg 51, 1949 EC Wijk aan Zee
Postbus 78, 1940 AB Beverwijk
University of Amsterdam
Intervention
Outcome measures
Primary outcome
1. Neuropsychological assessment;
2. functional assessment.
Secondary outcome
1. Sleep quality (actigraph);
2. Fatige (CIS-20r);
3. Mood (HADS).
Background 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.
Study objective
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.
Study design
4 weeks and 3 months.
Intervention
CPAP treatment. Patients will be randomized between two groups:
1. Patients receive CPAP directly;
2. Patients will receive CPAP after 4 weeks.
Postbus 78
Justine Aaronson
Beverwijk 1940 AB
The Netherlands
+31 (0)88 9208013
j.aaronson@heliomare.nl
Postbus 78
Justine Aaronson
Beverwijk 1940 AB
The Netherlands
+31 (0)88 9208013
j.aaronson@heliomare.nl
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
neuropsychological assessment;
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 patient’s health if treatment is not immediately started.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3259 |
| NTR-old | NTR3412 |
| CCMO | NL37330.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36215 |