In this study the relation of OSAS with functional status and cognition, 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…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are cognitive and functional outcome.
Secondary outcome
Secondary measures are fatigue, mood and sleep quality. Sociodemographic and
clinical data, CPAP compliance, nocturnal arousal and rehabilitation therapy
will be included as control measures.
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 seems
to improve rehabilitation outcome of stroke patients.
Study objective
In this study the relation of OSAS with functional status and cognition, 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
Case-control study to address research question 1.
Randomized controlled trial to address research question 2.
Intervention
Stroke patients who screen positive for OSAS will be randomized over four weeks
of nocturnal use of CPAP and four weeks of CAP treatment dealy (N=70). These
patient groups will be compared at baseline, and after four weeks and three
months (RCT part of the project), and they will be compared to patients who
screen negative for OSAS (N=70; case-control part of the project).
Study burden and risks
All stroke patients admitted in Heliomare are screened for OSAS and undergo a
neuropsychological assessment and assessment of functional status as part of
the routine intake procedure. Present day Heliomare is the only rehabilitation
centre in the Netherlands that screens stroke patients for SAS;
neuropsychological evaluation is required by national guidelines for stroke
rehabilitation. Subjects with OSAS will be randomized to the experimental or
control condition and subjects without OSAS will be assigned to an
observational control group. All subjects will undergo two more cognitive and
functional assessments after the treatment period and at follow-up after two
months. Additionally, OSAS patients will be asked to undergo a polygraphic
sleep examination after the intervention period and at follow-up. In the
experimental condition four weeks of CPAP therapy will be given, while in the
control condition CPAP treatment is delayed for four weeks.
There is no risk associated with participation in this study.
Relweg 51
1949 EC Wijk aan Zee
NL
Relweg 51
1949 EC Wijk aan Zee
NL
Listed location countries
Age
Inclusion criteria
First-time stroke confirmed by neurological assessment and CT-scan or MRI-scan
Baseline measurement (T<=0) between 1 to 16 weeks after stroke
Able to cooperate with SAS screening and neuropsychological assessment
Informed consent for study participation
18-85 years of age
Obstructive or mixed SAS (for intervention part of the study)
Exclusion criteria
Severe unstable medical conditions
Severe cardiac problems (like angina pectoris or pacemaker/ventricular impairments)
Severe pulmonal disease (severe dyspnea of effort or severe pulmonal emphysema)
Severe aphasia or confusion, which could strongly influence the performance on the neuropsychological assessment
Severe psychiatric or somatic comorbidity, which could strongly influence the performance on the neuropsychological assessment
Central SAS only
Severe OSAS (AHI>60 in combination with desaturations below 70%), which could endanger patient's health if CPAP treatment is not immediately started
Obesity hypoventilation syndrome
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL37330.018.11 |
OMON | NL-OMON20314 |