In this study the effect of SAS and the treatment with CPAP on cognitive functioning, fatigue and mood in stroke patients will be investigated. The main research questions are: 1) Is there a relationship between (the severity of) SAS and cognitive…
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 outcomes of this study are fatigue, cognitive and emotional
functioning, and daily living activities (neuropsychological evaluation).
Secondary outcome
Secondary measures are sleep quality and cerebral functioning. Sociodemographic
and clinical data, CPAP compliance and nocturnal arousal will also be included
as control measures.
Background summary
Several studies have shown a relationship between (obstructive) sleep apnea
syndrome (SAS) and cardiovascular diseases, such as hypertension, heart disease
and stroke. SAS has also been associated with increase of fatigue and
depression, and a decrease of cognitive functioning, more particular in the
domains of attention and memory. Although research on SAS in stroke patients is
scarce, it seems that SAS has an additional negative effect on existing
cognitive deficits due to the stroke. Continuous positive airway pressure
(CPAP) is the most frequently used treatment for SAS.
In otherwise healthy SAS patients CPAP treatment has been found to improve
fatigue, cognitive functioning, mood and quality of life.
Study objective
In this study the effect of SAS and the treatment with CPAP on cognitive
functioning, fatigue and mood in stroke patients will be investigated. The main
research questions are: 1) Is there a relationship between (the severity of)
SAS and cognitive functioning, mood, fatigue, sleep quality and cerebral
functioning? 2) Does decrease of SAS by means of adequate treatment like CPAP
improve cognitive functioning, mood, fatigue, sleep quality and cerebral
functioning? Firstly, we expect to confirm that SAS has an additional negative
effect in stroke patients on cognitive functioning, mood, fatigue and sleep
quality. Secondly, we expect that CPAP treatment will improve the sleep
quality, fatigue, mood and cognitive impairments, in particular in the stroke
affected domains.
Study design
3-arm, randomized, placebo-controlled crossover study
Intervention
Two weeks of nocturnal use of continuous positive airway pressure (CPAP), sham
CPAP or no treatment followed by two weeks of nocturnal CPAP or no treatment.
Study burden and risks
All stroke patients admitted in Heliomare revalidatie will be screened for SAS
and will undergo a neuropsychological assessment (T=0). Present day Heliomare
is the only rehabilitation centre in the Netherlands that screens stroke
patients as part of the usual intake procedure. Subjects with SAS will be
randomized to one of three experimental conditions and subjects without SAS
will be assigned to a control condition. All subjects will undergo a repeated
neuropsychological assessment. Additionally, SAS patients will be asked to
undergo a polygraphic sleep examination before and after the intervention
periods. In a subgroup of the SAS patients (N=36) an fMRI scan will also be
administered at the different time points. In the experimental condition CPAP
therapy will be given. Treatment will be delayed or discontinued for two weeks
or two weeks of placebo treatment will be given.
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 or MRI scan
Baseline measurement (T<=0) between 4 to 16 weeks after stroke
Able to cooperate with sleep apnea (SAS) screening and neuropsychological assessment
Informed consent for study participation
18-85 years of age
Obstructive or mixed SAS (for experimental group)
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
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36172.018.11 |