Skip to main content
OpenTrials
Completed

NCT Number: NCT02769663

Cognitive Complaints in Obstructive Sleep Apnea

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognition Disorders Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea Syndromes, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VieCuri Medisch Centrum, Venlo, Limburg, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

questionnaires and neuropsychological assessments

Behavioral

Primary outcomes

  1. Cognitive Failure Questionnaire (CFQ)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    Questionnaire assessing cognitive complaints

  2. Behavior Rating Inventory of Executive Function Adult version (BRIEF-A)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    Questionnaire assessing cognitive complaints

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire assessing anxiety and depressive symptoms

  2. Fatigue Assessment Scale (FAS)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire assessing fatigue

  3. Epworth Sleepiness Scale (ESS)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire assessing sleepiness

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire screening for sleep disorders and assessing sleep quality

  5. Sleep diary

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    subjective measure for sleep quality

  6. World Health Organisation Quality of Life Questionnaire BREF (WHOQOL-bref)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire measuring quality of life

  7. Utrechtse Coping Lijst (UCL)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    questionnaire measuring psychological coping strategies

  8. Dutch reading tests for adults (NLV)

    Time frame: Assessed at inclusion of study.

    cognitive test for verbal intelligence

  9. Central Nervous System Vital Signs Symbol Digit Coding (CNS-VS-SDC)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention

  10. Central Nervous System Vital Signs Continuous Performance Test (CNS-VS-CPT)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention

  11. Central Nervous System Vital Signs Stroop Test (CNS-VS-ST)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention/executive function

  12. Central Nervous System Vital Signs Shifting Attention Test (CNS-VS-SAT)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention/executive function

  13. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for memory

  14. Wechsler Adult Intelligence Scale III - Digit Span (WAIS-III-DS)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention/executive function

  15. Trail Making Test (TMT)

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for attention/executive function

  16. Semantic Fluency

    Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

    cognitive test for executive function

Sponsors and collaborators

Lead sponsor

VieCuri Medical Centre

Other

Collaborators

  • Reinier de Graaf Groep
  • Tilburg University

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
May 11, 2016
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.