Cognitive Complaints in Obstructive Sleep Apnea

July 12, 2020 updated by: Tim Vaessen, VieCuri Medical Centre
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
Questionnaire assessing cognitive complaints
Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
questionnaire assessing fatigue
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.
questionnaire assessing sleepiness
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.
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
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
questionnaire measuring quality of life
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.
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)
Time Frame: Assessed at inclusion of study.
cognitive test for verbal intelligence
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.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
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)
Time Frame: Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.
cognitive test for attention/executive function
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.
cognitive test for executive function
Assessed at inclusion of study and, if treatment is started, after 6 months of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VieCuri Medical Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tilburg University
Reinier de Graaf Groep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Margriet Sitskoorn, PhD, Tilburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABR 37795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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