Cognitive Complaints in Obstructive Sleep Apnea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OSA Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition. |
Behavioral: questionnaires and neuropsychological assessments
|
| healthy controls Participants with no sleep disorder or other medical comorbidity affecting cognition. |
Behavioral: questionnaires and neuropsychological assessments
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
native Dutch speaker
-
estimated verbal-IQ of ≥80
Exclusion Criteria:
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VieCuri Medisch Centrum | Venlo | Limburg | Netherlands | 5912 BL |
| 2 | Reinier de Graaf Gasthuis | Delft | Zuid-Holland | Netherlands | 2625 AD |
Sponsors and Collaborators
- VieCuri Medical Centre
- Tilburg University
- Reinier de Graaf Groep
Investigators
- Study Director: Margriet Sitskoorn, PhD, Tilburg University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABR 37795