Obstructive Sleep ApneaCARDOSANCT07427589
Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Cardiovascular (CV) Risk, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Cardiovascular (CV) Risk
- What is being tested?
- Continuous positive airway pressure, Mandibular advancement device and Hypoglossal nerve stimulation
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jun 2026to Dec 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Antwerp
Prof. Marijke Dieltjens, 038215221
About this study
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.
- Conditions
- Obstructive Sleep Apnea, Cardiovascular (CV) Risk
- Being tested
- Continuous positive airway pressure, Mandibular advancement device, Hypoglossal nerve stimulation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
CPAP remains the most commonly used treatment modality and is considered as the gold standard for patients with OSA because of its high efficacy and noninvasive nature. CPAP therapy is indicated for patients with moderate to severe OSA (AHI ≥ 15/h) or for those with a lower AHI with symptoms of excessive daytime sleepiness. It is effective in reducing nocturnal obstructive events by delivering continuous positive airway pressure, which functions as a pneumatic splint to keep the upper airway open and prevent pharyngeal collapse during sleep [16]. CPAP therapy generally improves sleep parameters, enhances blood oxygen saturation and causes disappearing of OSA-related symptoms. Although CPAP is really effective in treating OSA, many patients struggle with intolerance and long-term adherence remains a significant challenge.
Mandibular advancement deviceDevice
Mandibular advancement device (MAD) has become a widely recognized non-invasive treatment alternative for patients who cannot tolerate CPAP. It is primarily indicated for mild to moderate OSA and lately also for severe OSA patients. These MADs are worn intraorally during the night and attach to both upper and lower dental arches, protrude the lower jaw to widen and reopen the upper airway.
Hypoglossal nerve stimulationDevice
Hypoglossal nerve stimulation (HNS) is a novel and unique therapeutic option for patients with moderate-to-severe OSA who cannot be treated effectively with CPAP or MAD. In contrast to traditional reconstructive procedures for OSA, which focus only on anatomical adjustments, HNS integrates a surgical implantation process with an adjustable medical device to open the upper airway through neuromodulation of the hypoglossal nerve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular outcome: interventricular septum thickness
Interventricular septal thickness will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
Measured: 1 year
Secondary outcomes (14)
Sleep apnea-specific hypoxic burden (SASHB)
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.
Measured: 1 year
Heart rate response to a respiratory event (ΔHR)
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.
Measured: 1 year
Pulse wave amplitude drops (PWADs)
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.
Measured: 1 year
Cardiovascular outcome: heart rate variability
Heart rate variability will be calculated from ECG-derived RR intervals obtained during the sleep study.
Measured: 1 year
Cardiovascular outcome: left ventricular ejection fraction
Left ventricular ejection fraction will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
Measured: 1 year
Cardiovascular outcome: left ventricular mass
Left ventricular mass will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
Measured: 1 year
Cardiovascular outcome: 24-hour ambulatory blood pressure
24-hour ambulatory blood pressure will be measured using ambulatory blood pressure monitoring (ABPM).
Measured: 1 year
Cardiovascular outcome: systolic and diastolic function
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.
Measured: 1 year
OSA efficacy: delta apnea-hypopnea index (AHI)
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.
Measured: 1 year
Oxygen desaturation index (ODI)
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.
Measured: 1 year
Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use
Average hours of therapy use per night and the number of nights per week can be retrieved from data stored in the device.
Measured: 1 year
Degree of snoring measured by Visual Analogue Scale (VAS)
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.
Measured: 1 year
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
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.
Measured: 1 year
Fatigue measured by the Checklist Individual Strength (CIS) questionnaire
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Jun 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427589
- Sponsor's protocol ID
- 4699
- Other IDs
- G063725N
- Acronym
- CARDOSA
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07427589
- Acronym / sponsor ID
- CARDOSA / 4699
- Conditions
- Obstructive Sleep Apnea, Cardiovascular (CV) Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Feb 2026 (actual)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Continuous positive airway pressureCPAP remains the most commonly used treatment modality and is considered as the gold standard for patients with OSA because of its high efficacy and noninvasive nature. CPAP therapy is indicated for patients with moderate to severe OSA (AHI ≥ 15/h) or for those with a lower AHI with symptoms of excessive daytime sleepiness. It is effective in reducing nocturnal obstructive events by delivering continuous positive airway pressure, which functions as a pneumatic splint to keep the upper airway open and prevent pharyngeal collapse during sleep [16]. CPAP therapy generally improves sleep parameters, enhances blood oxygen saturation and causes disappearing of OSA-related symptoms. Although CPAP is really effective in treating OSA, many patients struggle with intolerance and long-term adherence remains a significant challenge. | Device | – |
| Mandibular advancement deviceMandibular advancement device (MAD) has become a widely recognized non-invasive treatment alternative for patients who cannot tolerate CPAP. It is primarily indicated for mild to moderate OSA and lately also for severe OSA patients. These MADs are worn intraorally during the night and attach to both upper and lower dental arches, protrude the lower jaw to widen and reopen the upper airway. | Device | – |
| Hypoglossal nerve stimulationHypoglossal nerve stimulation (HNS) is a novel and unique therapeutic option for patients with moderate-to-severe OSA who cannot be treated effectively with CPAP or MAD. In contrast to traditional reconstructive procedures for OSA, which focus only on anatomical adjustments, HNS integrates a surgical implantation process with an adjustable medical device to open the upper airway through neuromodulation of the hypoglossal nerve. | Device | – |
Primary outcome
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.
14 secondary outcomes
Sleep apnea-specific hypoxic burden (SASHB)
Time frame: 1 year
Heart rate response to a respiratory event (ΔHR)
Time frame: 1 year
Pulse wave amplitude drops (PWADs)
Time frame: 1 year
Cardiovascular outcome: heart rate variability
Time frame: 1 year
Cardiovascular outcome: left ventricular ejection fraction
Time frame: 1 year
Cardiovascular outcome: left ventricular mass
Time frame: 1 year
Cardiovascular outcome: 24-hour ambulatory blood pressure
Time frame: 1 year
Cardiovascular outcome: systolic and diastolic function
Time frame: 1 year
OSA efficacy: delta apnea-hypopnea index (AHI)
Time frame: 1 year
Oxygen desaturation index (ODI)
Time frame: 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
Degree of snoring measured by Visual Analogue Scale (VAS)
Time frame: 1 year
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time frame: 1 year
Fatigue measured by the Checklist Individual Strength (CIS) questionnaire
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Cardiovascular (CV) Risk, run by University Hospital, Antwerp at 1 site in Belgium.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Marijke Dieltjens (038215221, marijke.dieltjens@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular outcome: interventricular septum thickness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.