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Cognitive Complaints in Obstructive Sleep Apnea

Cognitive Complaints in Obstructive Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02769663
Enrollment
180
Registered
2016-05-11
Start date
2012-06-01
Completion date
2019-02-18
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders, Sleep Apnea Syndromes, Obstructive

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.

Interventions

BEHAVIORALquestionnaires and neuropsychological assessments

Sponsors

Tilburg University
CollaboratorOTHER
Reinier de Graaf Groep
CollaboratorOTHER
VieCuri Medical Centre
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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
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
Sleep diaryAssessed at inclusion of study and, if treatment is started, after 6 months of treatment.subjective measure for sleep quality
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 FluencyAssessed at inclusion of study and, if treatment is started, after 6 months of treatment.cognitive test for executive function
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
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026