Cognitive Complaints in Obstructive Sleep Apnea
- Conditions
- Cognition DisordersSleep Apnea Syndromes, Obstructive
- Interventions
- Behavioral: questionnaires and neuropsychological assessments
- Registration Number
- NCT02769663
- Lead Sponsor
- VieCuri Medical Centre
- Brief Summary
The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared to healthy controls matched on age, sex and educational level. Factors related to cognitive complaints will also be assessed, including anxiety and depressive symptoms, complaints of fatigue and sleepiness, quality of life, psychological coping strategies and objective measures of cognition. Patients starting treatment for sleep apnea (continuous positive airway pressure or mandibular repositioning device) will be reassessed on all measures after 6 months of treatment to study the impact of treatment as usual on cognitive complaints and its related factors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- native Dutch speaker
- estimated verbal-IQ of ≥80
- other sleep disorder than obstructive sleep apnea
- substance or alcohol abuse (e.g. no more than three units of alcohol per day for males and no more than two units of alcohol per day for females
- diagnosis of a psychiatric disorder
- use of medication effecting cognition
- neurological disease, diabetes mellitus, hypo- or hyperthyroidism or lung disease (as checked by verbal report and medical records)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OSA questionnaires and neuropsychological assessments Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition. healthy controls questionnaires and neuropsychological assessments Participants with no sleep disorder or other medical comorbidity affecting cognition.
- Primary Outcome Measures
Name Time Method Cognitive Failure Questionnaire (CFQ) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. Questionnaire assessing cognitive complaints
Behavior Rating Inventory of Executive Function Adult version (BRIEF-A) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. Questionnaire assessing cognitive complaints
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire assessing anxiety and depressive symptoms
Fatigue Assessment Scale (FAS) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire assessing fatigue
Epworth Sleepiness Scale (ESS) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire assessing sleepiness
Pittsburgh Sleep Quality Index (PSQI) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire screening for sleep disorders and assessing sleep quality
Sleep diary Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. subjective measure for sleep quality
World Health Organisation Quality of Life Questionnaire BREF (WHOQOL-bref) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire measuring quality of life
Utrechtse Coping Lijst (UCL) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. questionnaire measuring psychological coping strategies
Dutch reading tests for adults (NLV) Assessed at inclusion of study. cognitive test for verbal intelligence
Central Nervous System Vital Signs Symbol Digit Coding (CNS-VS-SDC) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention
Central Nervous System Vital Signs Continuous Performance Test (CNS-VS-CPT) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention
Central Nervous System Vital Signs Stroop Test (CNS-VS-ST) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention/executive function
Central Nervous System Vital Signs Shifting Attention Test (CNS-VS-SAT) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention/executive function
Rey Auditory Verbal Learning Test (RAVLT) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for memory
Wechsler Adult Intelligence Scale III - Digit Span (WAIS-III-DS) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention/executive function
Trail Making Test (TMT) Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for attention/executive function
Semantic Fluency Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. cognitive test for executive function
Trial Locations
- Locations (2)
VieCuri Medisch Centrum
🇳🇱Venlo, Limburg, Netherlands
Reinier de Graaf Gasthuis
🇳🇱Delft, Zuid-Holland, Netherlands