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.

Study Overview

• Status: Completed
• Conditions: Cognition Disorders; Sleep Apnea Syndromes, Obstructive
• Intervention / Treatment: Behavioral: questionnaires and neuropsychological assessments

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Venlo, Limburg, Netherlands, 5912 BL
      • VieCuri Medisch Centrum
  • Zuid-Holland
    • Delft, Zuid-Holland, Netherlands, 2625 AD
      • Reinier de Graaf Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA; Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition.	Behavioral: questionnaires and neuropsychological assessments
healthy controls; Participants with no sleep disorder or other medical comorbidity affecting cognition.	Behavioral: questionnaires and neuropsychological assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Failure Questionnaire (CFQ)	Questionnaire assessing cognitive complaints	Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: VieCuri Medical Centre
• Collaborators: Tilburg University; Reinier de Graaf Groep
• Investigators: Study Director: Margriet Sitskoorn, PhD, Tilburg University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 16, 2018
• Study Completion (Actual): February 18, 2019

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Cognition Disorders
• Other Study ID Numbers: ABR 37795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No