Cognitive Complaints in Obstructive Sleep Apnea

Cognition Disorders Clinical Trial

Official title:

Cognitive Complaints in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769663
• Other study ID #: ABR 37795
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Apnea
• Cognition Disorders
• Sleep Apnea Syndromes
• Sleep Apnea Syndromes, Obstructive
• Sleep Apnea, Obstructive

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.