Cognitive Complaints in Obstructive Sleep Apnea

NCT ID: NCT02769663

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-01

Study Completion Date

2019-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognition Disorders Sleep Apnea Syndromes, Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OSA

Patients with newly diagnosed obstructive sleep apnea and no medical comorbidity affecting cognition.

questionnaires and neuropsychological assessments

Intervention Type BEHAVIORAL

healthy controls

Participants with no sleep disorder or other medical comorbidity affecting cognition.

questionnaires and neuropsychological assessments

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaires and neuropsychological assessments

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tilburg University

OTHER

Sponsor Role collaborator

Reinier de Graaf Groep

OTHER

Sponsor Role collaborator

VieCuri Medical Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tim Vaessen

klinisch neuropsycholoog

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margriet Sitskoorn, PhD

Role: STUDY_DIRECTOR

Tilburg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VieCuri Medisch Centrum

Venlo, Limburg, Netherlands

Site Status

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40706402 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABR 37795

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Sleep Restriction
NCT01493661 COMPLETED
Sleep Aging and Risk for Alzheimer's 2.0
NCT03278119 ACTIVE_NOT_RECRUITING
Exploring the Link Between Sleep and Brain Clearance
NCT05539378 ENROLLING_BY_INVITATION NA