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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02769663
Other study ID # ABR 37795
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2012
Est. completion date February 18, 2019

Study information

Verified date July 2020
Source VieCuri Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date February 18, 2019
Est. primary completion date August 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
questionnaires and neuropsychological assessments


Locations

Country Name City State
Netherlands Reinier de Graaf Gasthuis Delft Zuid-Holland
Netherlands VieCuri Medisch Centrum Venlo Limburg

Sponsors (3)

Lead Sponsor Collaborator
VieCuri Medical Centre Reinier de Graaf Groep, University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive Failure Questionnaire (CFQ) Questionnaire assessing cognitive complaints Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Primary 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 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.
Secondary Fatigue Assessment Scale (FAS) questionnaire assessing fatigue Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary Epworth Sleepiness Scale (ESS) questionnaire assessing sleepiness Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary 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.
Secondary Sleep diary subjective measure for sleep quality Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary 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.
Secondary Utrechtse Coping Lijst (UCL) questionnaire measuring psychological coping strategies Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary Dutch reading tests for adults (NLV) cognitive test for verbal intelligence Assessed at inclusion of study.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Semantic Fluency cognitive test for executive function Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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