Cognitive Complaints in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Cognitive Failure Questionnaire (CFQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •native Dutch speaker
- •estimated verbal-IQ of ≥80
排除标准
- •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)
结局指标
主要结局
Cognitive Failure Questionnaire (CFQ)
时间窗: 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)
时间窗: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Questionnaire assessing cognitive complaints
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Fatigue Assessment Scale (FAS)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Epworth Sleepiness Scale (ESS)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Sleep diary(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)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Utrechtse Coping Lijst (UCL)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Dutch reading tests for adults (NLV)(Assessed at inclusion of study.)
- 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.)
- 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.)
- 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.)
- 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.)
- Rey Auditory Verbal Learning Test (RAVLT)(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)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Trail Making Test (TMT)(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
- Semantic Fluency(Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.)
研究者
Tim Vaessen
klinisch neuropsycholoog
VieCuri Medical Centre