Cognitive Complaints in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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Cognitive Complaints in Obstructive Sleep Apnea

Conditions
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Cognition Disorders, Sleep Apnea Syndromes, Obstructive

Intervention / Treatment
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* Behavioral: questionnaires and neuropsychological assessments


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA<br>Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition. | Behavioral: questionnaires and neuropsychological assessments<br> <br> |
| healthy controls<br>Participants with no sleep disorder or other medical comorbidity affecting cognition. | Behavioral: questionnaires and neuropsychological assessments<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Failure Questionnaire (CFQ) | Questionnaire assessing cognitive complaints | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Behavior Rating Inventory of Executive Function Adult version (BRIEF-A) | Questionnaire assessing cognitive complaints | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | questionnaire assessing anxiety and depressive symptoms | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Fatigue Assessment Scale (FAS) | questionnaire assessing fatigue | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Epworth Sleepiness Scale (ESS) | questionnaire assessing sleepiness | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Pittsburgh Sleep Quality Index (PSQI) | questionnaire screening for sleep disorders and assessing sleep quality | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Sleep diary | subjective measure for sleep quality | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| World Health Organisation Quality of Life Questionnaire BREF (WHOQOL-bref) | questionnaire measuring quality of life | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Utrechtse Coping Lijst (UCL) | questionnaire measuring psychological coping strategies | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Dutch reading tests for adults (NLV) | cognitive test for verbal intelligence | Assessed at inclusion of study. | 
| Central Nervous System Vital Signs Symbol Digit Coding (CNS-VS-SDC) | cognitive test for attention | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Central Nervous System Vital Signs Continuous Performance Test (CNS-VS-CPT) | cognitive test for attention | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Central Nervous System Vital Signs Stroop Test (CNS-VS-ST) | cognitive test for attention/executive function | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Central Nervous System Vital Signs Shifting Attention Test (CNS-VS-SAT) | cognitive test for attention/executive function | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Rey Auditory Verbal Learning Test (RAVLT) | cognitive test for memory | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Wechsler Adult Intelligence Scale III - Digit Span (WAIS-III-DS) | cognitive test for attention/executive function | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Trail Making Test (TMT) | cognitive test for attention/executive function | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. | 
| Semantic Fluency | cognitive test for executive function | Assessed at inclusion of study and, if treatment is started, after 6 months of treatment. |