Cognition DisordersNCT02769663
Cognitive Complaints in Obstructive Sleep Apnea
An observational study of Cognition Disorders and Sleep Apnea Syndromes, Obstructive, run by VieCuri Medical Centre at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cognition Disorders, Sleep Apnea Syndromes, Obstructive
- What is being tested?
- questionnaires and neuropsychological assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2012to 18 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- native Dutch speaker
- estimated verbal-IQ of ≥80
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD
VieCuri Medisch Centrum
Venlo, Limburg, 5912 BL
About this study
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.
- Being tested
- questionnaires and neuropsychological assessments
- Medical subject headings
- Cognition Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires and neuropsychological assessmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| OSA | Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition. Receives: Behavioral: questionnaires and neuropsychological assessments | |
| healthy controls | Participants with no sleep disorder or other medical comorbidity affecting cognition. Receives: Behavioral: questionnaires and neuropsychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Failure Questionnaire (CFQ)
Questionnaire assessing cognitive complaints
Measured: 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
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Secondary outcomes (16)
Hospital Anxiety and Depression Scale (HADS)
questionnaire assessing anxiety and depressive symptoms
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Fatigue Assessment Scale (FAS)
questionnaire assessing fatigue
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Epworth Sleepiness Scale (ESS)
questionnaire assessing sleepiness
Measured: 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
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Sleep diary
subjective measure for sleep quality
Measured: 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
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Utrechtse Coping Lijst (UCL)
questionnaire measuring psychological coping strategies
Measured: 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
Measured: Assessed at inclusion of study.
Central Nervous System Vital Signs Symbol Digit Coding (CNS-VS-SDC)
cognitive test for attention
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Semantic Fluency
cognitive test for executive function
Measured: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Jun 2012
- Primary completion16 Aug 2018
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, Reinier de Graaf Groep
- Responsible party
- Principal investigator, Tim Vaessen, VieCuri Medical Centre
- Investigators
- Margriet Sitskoorn, PhD, Study director, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769663
- Sponsor's protocol ID
- ABR 37795
- Status last verified
- Jul 2020
- First submitted
- 9 May 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vaessen TJA, Mark RE, Overeem S, Sitskoorn MM. Cognitive complaints in obstructive sleep Apnea: The overlooked role of coping styles. Sleep Med. 2025 Oct;134:106695. doi: 10.1016/j.sleep.2025.106695. Epub 2025 Jul 17.
PubMed 40706402
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Complaints in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02769663
- Acronym / sponsor ID
- ABR 37795
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Tilburg University, Reinier de Graaf Groep
- Study start
- 1 Jun 2012
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Behavioral: questionnaires and neuropsychological assessmentsPatients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition. |
| healthy controls | – | Behavioral: questionnaires and neuropsychological assessmentsParticipants with no sleep disorder or other medical comorbidity affecting cognition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- native Dutch speaker
- estimated verbal-IQ of ≥80
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires and neuropsychological assessments | Behavioural | OSA, healthy controls |
Primary outcome
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
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
16 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Fatigue Assessment Scale (FAS)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Epworth Sleepiness Scale (ESS)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Sleep diary
Time frame: 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)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Utrechtse Coping Lijst (UCL)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Dutch reading tests for adults (NLV)
Time frame: Assessed at inclusion of study.
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.
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.
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.
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.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 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)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Trail Making Test (TMT)
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Semantic Fluency
Time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 40706402Vaessen TJA, Mark RE, Overeem S, Sitskoorn MM. Cognitive complaints in obstructive sleep Apnea: The overlooked role of coping styles. Sleep Med. 2025 Oct;134:106695. doi: 10.1016/j.sleep.2025.106695. Epub 2025 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margriet Sitskoorn, PhD study director
Tilburg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorders and Sleep Apnea Syndromes, Obstructive, run by VieCuri Medical Centre at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Failure Questionnaire (CFQ) (time frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.