Clinical trial NCT02769663: Cognitive Complaints in Obstructive Sleep Apnea
Official title: Cognitive Complaints in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition Disorders
Sleep Apnea Syndromes, Obstructive
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: Reinier de Graaf Groep
First posted: 2016-05-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with obstructive sleep apnea according to the clinical guidelines of the adult OSA taskforce of the American Academy of Sleep Medicine (apnea/hypopnea-index (AHI) of ≥15 or AHI of ≥5 with significant daytime symptoms)

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.


Eligibility 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)

Primary outcomes:
measure: Cognitive Failure Questionnaire (CFQ)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Behavior Rating Inventory of Executive Function Adult version (BRIEF-A)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Fatigue Assessment Scale (FAS)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Sleep diary
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: World Health Organisation Quality of Life Questionnaire BREF (WHOQOL-bref)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Utrechtse Coping Lijst (UCL)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Dutch reading tests for adults (NLV)
timeFrame: Assessed at inclusion of study.
measure: Central Nervous System Vital Signs Symbol Digit Coding (CNS-VS-SDC)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Central Nervous System Vital Signs Continuous Performance Test (CNS-VS-CPT)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Central Nervous System Vital Signs Stroop Test (CNS-VS-ST)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Central Nervous System Vital Signs Shifting Attention Test (CNS-VS-SAT)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Wechsler Adult Intelligence Scale III - Digit Span (WAIS-III-DS)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Trail Making Test (TMT)
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
measure: Semantic Fluency
timeFrame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
state: Limburg
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid-Holland
Study officials:
affiliation: Tilburg University
name: Margriet Sitskoorn, PhD
role: STUDY_DIRECTOR
References: