Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea (CARDOSA)

June 24, 2026 updated by: University Hospital, Antwerp
The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.

Study Overview

Status

Status

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

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 (Estimated)

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.
270

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • Antwerp University Hospital
        • Contact:
          • Prof. Marijke Dieltjens
          • Phone Number: 038215221

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI≥15/h), recruited by the OSA multidisciplinary team.

Description

Inclusion Criteria:

  • AHI ≥ 15 events/hour, based on a recent (<2 years) PSG, conducted in Antwerp University Hospital
  • Patients must be 18 years or older
  • Patients must be dutch-speaking
  • Patients must be eligible for their therapy (CPAP, MAD or HNS)
  • Willing to participate after informed consent

Exclusion Criteria:

  • Central apneas accounting for ≥25% of total apneas during baseline polysomnography
  • Patients who have received effective CPAP therapy (defined as CPAP use for ≥4 h/night) within the previous 6 months
  • Patients with prior MAD therapy
  • Uncontrolled hypertension
  • Known cardiomyopathy
  • Significant coronary arterial disease
  • Clinically significant valvular heart disease, defined as more than mild left-sided valvular disease or more than moderate right-sided valvular disease
  • Congenital heart disease
  • Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria

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

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
Cardiovascular outcome: interventricular septum thickness
Time Frame: 1 year
Interventricular septal thickness will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
1 year

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
Sleep apnea-specific hypoxic burden (SASHB)
Time Frame: 1 year
This novel metric is calculated by determining the total area under the respiratory event-related desaturation curve, which can be obtained from a polysomnography (PSG). It has been shown to be a good predictor of cardiovascular disease mortality, but has not yet been established in daily practice.
1 year
Cardiovascular outcome: left ventricular ejection fraction
Time Frame: 1 year
Left ventricular ejection fraction will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
1 year
Cardiovascular outcome: heart rate variability
Time Frame: 1 year
Heart rate variability will be calculated from ECG-derived RR intervals obtained during the sleep study.
1 year
OSA efficacy: delta apnea-hypopnea index (AHI)
Time Frame: 1 year
The apnea-hypopnea Index (AHI), defined as the number of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep measured during a polysomnography, will be assessed. OSA is diagnosed when the AHI is at least 5/h. The AHI classifies OSA as mild with AHI ranging from 5 to 14.9 events per hour, moderate with AHI ranging from 15 to 29.9 events per hour and severe when 30 or higher events per hour.
1 year
Heart rate response to a respiratory event (ΔHR)
Time Frame: 1 year
ΔHR is defined as the difference between the maximum pulse rate after airway opening, i.e. during a subject-specific search window, and an event-related minimum pulse rate, i.e. minimum pulse rate during respiratory events. ΔHR will be calculated from a photoplethysmography (PPG), a signal derived from a finger pulse oximeter, which is part of the standard clinical PSG set-up.
1 year
Pulse wave amplitude drops (PWADs)
Time Frame: 1 year
PWADs can be calculated from photoplethysmography (PPG), a signal derived from a finger pulse oximeter, which is part of the standard clinical PSG set-up.
1 year
Cardiovascular outcome: 24-hour ambulatory blood pressure
Time Frame: 1 year
24-hour ambulatory blood pressure will be measured using ambulatory blood pressure monitoring (ABPM).
1 year
Cardiovascular outcome: systolic and diastolic function
Time Frame: 1 year
Left ventricular systolic and diastolic function will be evaluated using 2D echocardiography. Systolic function will be quantified by left ventricular ejection fraction calculated using the Simpson biplane method. Diastolic function will be assessed using pulsed wave tissue Doppler imaging at the septal and lateral mitral annulus, mitral inflow velocities (E/A ratio), the E/e' ratio and left atrial volume index.
1 year
Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use
Time Frame: 1 year
Average hours of therapy use per night and the number of nights per week can be retrieved from data stored in the device.
1 year
Degree of snoring measured by Visual Analogue Scale (VAS)
Time Frame: 1 year
Visual analogue scale for snoring, from 0 to 10: 0 represents no snoring, 1-3 represents minimally annoying, 4-6 represents moderately annoying, 7-9 represents annoying, and 10 represents extremely annoying.
1 year
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time Frame: 1 year
Daytime sleepiness measured using the Epworth sleepiness scale (ESS), which is a self-administered questionnaire that assesses the likelihood of falling asleep in various settings and situations in daily life.The questionnaire consists of eight items scored from 0 to 3, resulting in a total score ranging from 0 to 24. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event.
1 year
Fatigue measured by the Checklist Individual Strength (CIS) questionnaire
Time Frame: 1 year
Fatigue was assessed using the checklist individual strength, a 20-item questionnaire with each item scored on a 7-point Likert scale, resulting in total scores ranging from 20 to 140. Higher scores indicate greater fatigue severity.
1 year
Cardiovascular outcome: left ventricular mass
Time Frame: 1 year
Left ventricular mass will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
1 year
Oxygen desaturation index (ODI)
Time Frame: 1 year
The oxygen desaturation index (ODI) represents the number of oxygen desaturation events per hour of sleep, typically defined as a ≥3% or ≥4% drop in arterial oxygen saturation from baseline.
1 year

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.
University Hospital, Antwerp

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 (Actual)

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 10, 2026

Primary Completion (Estimated)

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.
December 1, 2029

Study Completion (Estimated)

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.
December 1, 2029

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).
January 30, 2026

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.
February 20, 2026

First Posted (Actual)

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.
February 23, 2026

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.
June 29, 2026

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.
June 24, 2026

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.
January 1, 2026

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.
  • 4699
  • G063725N (Other Identifier: FWO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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