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NCT Number: NCT07427589

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Antwerp, Belgium

Location status: Recruiting

Location contact

Prof. Marijke Dieltjens

CONTACT

038215221

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

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 device

Device

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 Stimulation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Marijke Dieltjens

CONTACT

[email protected]

038215221

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Acronym: CARDOSA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 23, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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